CRAB attends Life Science Innovation Northwest 2022 conference
Cancer Research And Biostatistics (CRAB) would like to congratulate our board member, Patrick Heagerty, PhD, on his election to the National Academy of Medicine (NAM). Election to the Academy is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.
CRAB presented as well as hosted a display table at the Life Science Innovation Northwest (LSINW) conference. This presentation took place Wednesday, April 20 in the Cellular, Laboratory, & Manufacturing Services Session. CRAB was honored to connect with the Pacific Northwest’s community of scientists, entrepreneurs and researchers from various healthcare or research organizations and institutions. We look forward to showcasing our services and capabilities as well as sharing discourse and networking with fellow colleagues and attendees in future conferences.
CRAB Board of Directors Member, Patrick Heagerty, Elected to National Academy of Medicine
Cancer Research And Biostatistics (CRAB) would like to congratulate our board member, Patrick Heagerty, PhD, on his election to the National Academy of Medicine (NAM). Election to the Academy is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.
“I’m truly honored that Patrick serves on our Board of Directors,” said Antje Hoering, PhD, CRAB President and CEO.
Dr. Heagerty is currently professor of the Department of Biostatistics, the director of the Center for Biomedical Statistics and former chair of the Department of Biostatistics at the University of Washington. Dr. Heagerty was recognized by the Academy for his development of novel statistical models for longitudinal data to better diagnose disease, track its trajectory, and predict its outcomes. He has revolutionized how dynamic predictors are judged by their discrimination and calibration and has significantly advanced methods for randomized controlled trials.
Established originally as the Institute of Medicine in 1970 by the National Academy of Sciences, the National Academy of Medicine addresses critical issues in health, science, medicine, and related policy. With their election, NAM members make a commitment to volunteer their service in National Academies activities.
CRAB CEO Joins Women & Diversity in Precision Medicine Panel
Cancer Research And Biostatistics (CRAB) CEO and President, Antje Hoering, PhD, joined the Women & Diversity in Precision Medicine pre-conference day for a panel discussion. The digital event brought together leaders of the scientific and business community, from pharma, diagnostic companies and academic institutions to foster collaboration, advocate mentor-ship and derive actionable solutions to help improve inclusion across the industry.
Through dynamic panels, including “The Collective Benefits and Practical Application of Mentoring Schemes,” this event facilitated meaningful connections on a conversation key to accelerating progress in the fast paced precision medicine industry. This panel explored the benefits of developing a balanced team perspective through diversified management and mentorship schemes. Dr. Hoering served as the panel chair along with panelists from AstraZeneca, Seuss+, Origami Therapeutics and Blueprint Medicines. “This forum allowed for an exchange on information on this timely and important topic,” said Dr. Hoering.
Following the Women & Diversity in Precision Medicine pre-conference day, the Digital Clinical Biomarkers & World CDx 3-day digital conference addressed the critical lessons learned both from personalized therapy case studies and the response to the pandemic, allowing for teams to more effectively deliver for patients in need across existing therapeutic areas.
CRAB Serving as the Independent Analysis Center for Circulating Tumor DNA Project
Cancer Research and Biostatistics (CRAB) is pleased to have been serving as the Independent Analysis Center (IAC) for a circulating tumor DNA project led by Friends of Cancer Research (Friends) since December 2019. According to Friends, this project aims, “to harmonize the use of circulating tumor DNA (ctDNA) to monitor treatment response (ctMoniTR) in patients with cancer and test the feasibility of data comparison from different clinical studies.”
Friends developed a proposal for ctMoniTR based off previous work in the field, the Friends Annual Meeting 2018, and the resulting whitepaper. In February of 2019, Friends reviewed the proposal during a full-day roundtable involving more than a dozen pharmaceutical companies, diagnostic companies, non-profit organizations, and members of the U.S. FDA and executed the collaborative project. Friends posted a press release announcing the launch of the ctMoniTR project in November 2019. CRAB was selected as the IAC from a competitive application process in December 2019.
The ctMoniTR project consists of two steps. Step 1 will utilize previously collected trial data to assess the feasibility of using ctDNA as a monitoring tool and of harmonizing across different datasets. There are 10 partners involved in Step 1, including AstraZeneca, Bristol-Myers Squibb, Genentech, Guardant Health, Johns Hopkins University, LexentBio, Merck, the NMD Group LLC, Roche Dx, and the U.S. Food and Drug Administration. The results from Step 1 will be used to inform Step 2, which will investigate ctDNA’s ability to detect tumor response to cancer therapies and treatment.
As the IAC for the ctMoniTR project, CRAB has received data from the pharmaceutical and diagnostic partners, coordinated input from collaborators, harmonized and pooled data, and analyzed the pooled data to meet the project’s objectives.
Exciting results for Step 1 were presented on August 11, 2020 via a Friends virtual meeting which began at Noon EDT (registration required). Over 900 attendees joined the virtual meeting. Antje Hoering, PhD, CRAB President and CEO, served on a live panel discussion following the presentation. The presentation is now available on YouTube.
Continuing the dialogue from the virtual meeting, Friends will be hosting a Virtual Q&A as an exclusive opportunity to meeting registrants. The Virtual Q&A will allow for further discussion on questions from the previous meeting, provide the chance to interact with experts from ctMoniTR, and further describe the results of Step 1 and setting the stage for Step 2.
Friends is a non-profit cancer research and advocacy organization based in Washington D.C.
Announcing the John Crowley, PhD Award
Cancer Research And Biostatistics (CRAB) is proud to announce The Hope Foundation for Cancer Research’s (The Hope Foundation) newest funding program: The John Crowley, PhD Award encouraging statistical excellence in clinical trials. In honor of Dr. Crowley’s history with the SWOG Cancer Research Network and The Hope Foundation, The John Crowley, PhD Award builds on Dr. Crowley’s legacy of mentorship and innovation by launching a biostatistical residency program. The Crowley Award provides a unique opportunity to work with experts at the SWOG Statistics and Data Management Center (SDMC) for one month. This interactive mentorship program will be a collective effort between CRAB, the SWOG SDMC, and The Hope Foundation.
“I am very grateful to the SWOG Cancer Research Network and The Hope Foundation for creating this program in my name,” says John Crowley, CRAB’s Chief of Strategic Alliances. “The one-month residency is a great opportunity for early to mid-career investigators to interact with statisticians in SWOG and to learn of the rich resource which constitutes the SWOG database. I expect that many fruitful collaborations will result."
To get full details, visit the program page on the Hope website.
Throughout his career Dr. Crowley has been a central force in SWOG and has made a significant impact on the field of biostatistics. Dr. Crowley served as the SWOG Group Statistician and Director of the Statistical Center from 1984 to 2012, and founded CRAB in 1997. He is known for his focus on design of cancer clinical and translation trials as well as his development of sophisticated tools for survival data. Dr. Crowley’s credentials include prestigious fellowships from the American Statistical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science; the Mortimer Spiegelman Award for Outstanding Young Biostatistician, the Marvin Zelen Award for Leadership in Statistical Science, and the Breslow Lectureship. Dr. Crowley continues to be active in SWOG, particularly with the SWOG Latin American Initiative.
CRAB Statistical Tools Updated and Expanded
Thus far in 2020, we have developed a new utility tool to easily convert between survival and hazard rates and updated the Two Arm Binomial, Two Arm Survival, and Two-Stage calculator interfaces to be more intuitive and include additional helpful outputs. Additionally, the Two-Stage calculator was revised to include new methodology, developed by the SWOG SDMC in 2019, which extends the calculations to allow stopping for efficacy, not just futility, during the interim analysis. A manuscript has been submitted for publication.
In 2019, two new tools were developed, one that uses simulation to calculate the prognostic power of a continuous marker and another to determine survival for subgroups in a prognostic marker study. We also refined the Binomial Noninferiority calculator to make it more intuitive.
“These calculators are intuitive and easy to use and are being used by many researchers and clinicians worldwide,” said Antje Hoering, PhD, CRAB President and CEO. “We hope that these updates make them even more attractive.”
The calculators are publicly available to researchers worldwide. SWOG and CRAB statisticians use the tools to teach clinicians the basics of clinical trial design. An oral presentation by developers at the 40th Annual Society for Clinical Trials conference last year highlighted many of the improvements.
CRAB's Collaboration with OHSU Knight Cancer Insitute
This year marked the fifth year of the collaboration between CRAB and the Biostatistics Shared Resource (BSR) team at the Oregon Health and Science University (OHSU) Knight Cancer Institute. The collaboration combines CRAB’s expertise in designing clinical trials, oncology analytics, identification of genetic markers and targeted designs with the OHSU Knight Cancer Institute’s pioneering work in personalized cancer medicine and proficiency in early detection of cancer along with its leadership in research and cancer treatment.
In January, CRAB President and CEO Antje Hoering, PhD, joined BSR statisticians at the fourth Clinical Trials Methods Training & Workshop for medical doctors and allied health professionals. The workshop included didactic lectures followed by small group discussions of specific proposed protocols.
“I’m impressed by the ever-improving quality of this workshop at the Knight Cancer Institute,” said Dr. Hoering. “It’s hugely popular and draws many participants each year.”
News & Events > Archive
CRAB Mourns Loss of Renowned SWOG Leader
It is with great sadness that we comment on the passing of Dr. Charles A. Coltman, Jr. – SWOG Group Chair, influential cancer researcher, and tireless patient advocate.
Dr. Charles Coltman was dedicated to improving the lives of cancer patients through clinical trials and drug development. He had a 20-year career in the U.S. Air Force from 1957 – 1977, where he reached the rank of Colonel. During this time, he served for more than a decade as chief of hematology/oncology at Wilford Hall Air Force Hospital and was appointed consultant in hematology to the U.S. Surgeon General. After his distinguished military career, Dr. Coltman went on to hold numerous high-ranking leadership positions - often simultaneously! In addition to serving as both an National Institutes of Health (NIH) Cancer Center Director and Cooperative Group Chair, he served as President and Director of the San Antonio Cancer Institute, Chief Executive Officer and Medical Director of the Cancer Therapy and Research Center (San Antonio, Texas), and President of the American Society of Clinical Oncology.
Dr. Coltman made his most impactful contributions to cancer research and clinical trial and drug development within the SWOG Cancer Research Network, funded through the National Cancer Institute. As Group Chair of SWOG, then known as the Southwest Oncology Group, from 1981 to 2005, he was instrumental in establishing the role of research groups in cancer treatment and prevention. A visionary leader, Dr. Coltman engineered the move of the SWOG Statistics and Data Management Center (SDMC) from Houston to Seattle where the center was placed under the leadership of John Crowley, PhD, who later co-founded CRAB. Dr. Coltman mandated the use appropriate technology to improve data quality, a directive that Dr. Crowley embraced in establishing the SWOG SDMC at Fred Hutchinson Center and later at CRAB. The SWOG SDMC is now hosted jointly at Fred Hutch and CRAB.
Over the course of his leadership tenure, Dr. Coltman founded The Hope Foundation to support the SWOG community and launched SWOG’s patient advocacy program (the oldest and largest in the National Clinical Trials Network). He also helped to build SWOG’s Young Investigator Training Course, which has trained 100 participants since 1999. He was instrumental in launching SWOG’s two landmark cancer prevention trials – the Selenium and Vitamin E Cancer Prevention Trial, or SELECT, and the Prostate Cancer Prevention Trial. Together, those studies enrolled more than 53,000 men. One of Chuck’s last efforts in SWOG was to fund, through The Hope Foundation, a series of research workshops aimed at identifying cancer burdens in Latin America, which led to a study of methods to eradicate helicobacter pylori, the bacterium that is a major cause of stomach cancer.
“Chuck was a brilliant medical oncologist who was quick to grasp the latest in translational science,” said Dr. Crowley. “In a Group with an assortment of large egos and personalities, he commanded respect. I loved to listen to him tell stories of his diagnostic prowess, like how he got his son off the baseball field and into the operating room with a ruptured spleen. I still find myself using words, expressions and phrases I got from him – Coltmanisms like: ‘Alphabetagooferdust’ and ‘difungomuctane’ to describe the latest drug combos; ‘That good, eh?’ when someone said they were just ‘ok’; and my favorite way to close a meeting, ‘Everyone opposed to adjourning, please remain seated.’ He is missed.”
Thank you, Dr. Coltman for your vision, leadership and advocacy.
In lieu of flowers, donations are welcomed by The Hope Foundation for Cancer Research (thehopefoundation.org) at 24 Frank Lloyd Wright Drive, P.O. Box 483, Ann Arbor, ME 48105.
CRAB Showcases Tech Clinical Trials Conference
Representing the SWOG Cancer Research Network and CRAB at the annual conference for the Society for Clinical Trials (SCT), Chris Cook and Angela Smith engaged audiences as they spoke to their respective areas of expertise.
Angela presented on the Statisticians' Report Worksheet (SRW), an application used by SWOG statisticians to generate study reports. Angela presented an abstract and slides authored by Katie Snapinn which included the latest changes being implemented to SRW, most importantly the switch to using R instead of SAS statistical package. "I could tell that the attendees were impressed by the application," Angela said.
Showcasing the statistical tools developed by SWOG and used by statisticians and clinicians worldwide at stattools.crab.org, Chris Cook focused on recent changes that were implemented to make the tools more accessible and easier to use. "The conference gives [us] an opportunity to take a step back from day to day work and get a broader perspective of clinical trials and how we can make an impact," Chris said.
SWOG Group Chair Dr. Charles Blanke drove home the importance of SWOG having a presence at event like the SCT conference in a recent Front Line newsletter. "Saying we value our SWOG Cancer Research Network statisticians would be the understatement of the year," he wrote. "They literally power our trials, which is why they are placed into the second author slot on all of our primary clinical trials publications. Sometimes they play larger roles and merit higher placement." Dr. Blanke congratulated the SWOG investigators, statisticians, and abstract presenters who were featured at the SCT conference.
The Society for Clinical Trials is an organization "whose mission is to work internationally to advance human health through advocating the use of clinical trials, leading the development and dissemination of optimal methods and practices in clinical trials, and educating and developing all clinical trial professionals." This year's focus for the 40th Annual SCT conference in New Orleans which took place 19 to 22 May 2019, was "Clinical Trials: A Catalyst for Societal Advancement through Innovation." Both Chris and Angela encourage others at CRAB to consider submitting abstracts for posters or presentations at future SCT meetings.
CRAB CEO presents at AACR Annual Meeting
Antje Hoering, PhD, CRAB President and CEO, shared her expertise on targeted therapy clinical trial design with a crowd of hundreds as an invited speaker in an educational session at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta on March 29.
Dr. Hoering’s session, titled “Precision Oncology: Integrating Biomarkers in Phase III Clinical Trial Designs,” focused on how to best design clinical trials for targeted therapy. Several hundred people attended the session, including many young career fellows in clinical and biochemistry labs. Dr. Hoering spoke in a block of four total speakers who each focused on different facets of biomarkers and targeted therapy.
In the last decade, cancer treatment has incorporated more and more targeted therapy, Dr. Hoering said. Compared to chemotherapy, which impacts all dividing cells, targeted therapy seeks out specific molecular pathways and targets only those affected cells, creating a more focused treatment, she said.
Speaking to her involvement in the oncology industry as targeted therapies have developed, Dr. Hoering said: “It’s very gratifying to help in any way, to get the right answers to the therapeutic questions as efficiently as possible.”
AACR is a national organization founded in 1907 that aims to prevent and cure cancer through research, education, communication, collaboration, funding, and advocacy, according to AACR.org. The organization is linked to multiple industry-respected publications, including Cancer Today.
Dr. Hoering also presented at AACR in 2014.
News & Events > Archive
CRAB CEO gives stats lecture at annual ASH conference, awarded membership
Cancer Research And Biostatistics CEO and President, Antje Hoering, PhD, gave a statistics-focused presentation at the trainee didactic session at the American Society of Hematology’s (ASH) annual conference in San Diego, CA in December 2018.
Dr. Hoeing’s well-attended lecture, “Basic Statistics for Hematologists,” emphasized statistical methods and tools to help hematologists’ operational knowledge of statistics for their own research and showcased CRAB’s and SWOG’s proprietary statistical tools.
For a statistician to take the main stage at a large medical meeting such as ASH is a rare and exciting opportunity, as statistics is often seen in a supporting role, Dr. Hoering said.
“There’s a real need, as clinicians are often not educated enough in the field of statistics but really need it to advance their research. I also always look for opportunities to showcase CRAB,” she said. Empowering people to help themselves has been a long-standing theme in Dr. Hoering’s career, choosing to focus her expertise on application over methodology.
“I personally prefer empowering others,” she said.
Dr. Hoering, who holds affiliate appointments at the Department of Biostatistics at the University of Washington and the Fred Hutch Cancer Research Center in Seattle, in 2017 and 2018 served as a mentor to hematology fellows and junior faculty through ASH’s Clinical Research Training Institute. She will continue this mentorship in 2019.
“It’s gratifying to teach young researchers and help them accomplish their career goals,” she said.
In December 2018, Dr. Hoering was also awarded an ASH membership, recognizing her as an influencer in the hematology field.
CRAB Senior Biostatistician, Katie Nishimura, PhD, also presented a poster at the ASH conference titled “Sequential improvements in the outcome of autologous stem cell transplantation for multiple myeloma over time.” Dr. Nishimura, who has first author credit on the study, points to evidence of “a functional cure” for multiple myeloma, a cancer most clinicians still consider incurable, she said. It was Nishimura’s first presentation and attendance at ASH.
ASH was founded in 1958 and with 17,000 members from 100 countries is the largest professional society serving clinicians and scientists, according to ASH.org.
Rural and Urban Cancer Patients with Similar Access to Care Survive at Similar Rates, SWOG Study Shows
A 2018 SWOG Cancer Research Network analysis of decades of data shows that, when enrolled on cancer clinical trials, cancer patients in rural and urban areas have similar survival rates. Previous studies have not factored in access to clinical trials when reviewing cancer patient survivor rates in rural versus urban areas, according to the study,“Geographic Distribution and Survival Outcomes for Rural Patients with Cancer Treated in Clinical Trials.”
The study, published on JAMA Network in August 2018, examined data from nearly 37,000 patients enrolled in phase II and phase III clinical trials between 1986 and 2012 treating 17 different cancer types. The study showed patients from rural and urban areas have similar outcomes in survival and recovery when given similar access to clinical trials.
“This finding suggests that improving access to uniform treatment strategies for patients with cancer may help resolve the disparity in cancer outcomes between rural and urban patients,” said Joseph Unger, PhD, SWOG biostatistician and first author on the study.“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care.”
Study authors include Unger and Anna Moseley – who both work at the SWOG Statistics and Data Management Center in Seattle – and Dr. Banu Symington, Dr. Mariana Chavez-MacGregor, Dr. Scott Ramsey, and Dr. Dawn Hershman. CRAB is part of the SWOG Statistics and Data Management Center, which includes Fred Hutchinson Cancer Research Center.
In an invited commentary also appearing in JAMA Network, Dr. Lauren McCullough and Dr. Christopher Flowers praised the study, saying it shows that rural status is not an automatic predictor of survival chances, but that enrollment on cancer clinical trials results in survival rates – regardless of urban or rural geography.
“These data suggest that receipt of guideline-driven cancer care, as provided in clinical trials, may be a feasible approach to eliminate the cancer survival disparities between rural and urban patients,” McCullough and Flowers said in a joint statement.
CRAB Moves to West Lake Union
After almost 20 years at our Metropolitan Park location, CRAB has moved to West Lake Union Center located on beautiful Lake Union. We remain in close proximity to key partners including the Fred Hutch and are excited to continue our effort to fight cancer, one clinical trial at a time.
Aligning Vision with Community, CRABCares Gives Back
CRABCares, an employee-driven volunteer program, promotes participation in events that align with CRAB's vision to end suffering from cancer. The program was launched in 2013 as a grassroots movement to integrate CRAB with its local community and to promote a service-based community within CRAB.
The CRABCares Committee organizes three to five events each year, which link staff members, family, and friends of CRAB to events that advance research, support patients, raise awareness, and create hope for cancer survivorship. Common events have included the Leukemia and Lymphoma Society Big Climb, the American Lung Association Lung Force Walk, and the Pancreatic Cancer Action Network Purple Stride.
In addition to cancer-centered events, CRABCares expanded its outreach to address other issues that affect members of Seattle's community. Annually, CRABCares provides lunch at the YouthCare Orion Center for children, youth, and young adults battling homelessness.
In 2017, CRABCares added support for the Washington Talking Book & Braille Library, a Seattle-based library that provides services and resources to Washington residents who are unable to read standard print. "Last year was the first year we volunteered at the Washington Talking Book & Braille Library where we received pleasant feedback from CRAB participants," said Heidi Dong, the current CRABCares Chair. "We can give back in various ways. For CRAB to offer a committee like this shows that we are committed to fighting cancer in different ways, and that we really do care about the community around us. I think it also provides us as employees who participate in these events a sense of awareness and empathy."
CRABCares Reaches New Heights at the 2018 Big Climb
On Sunday, March 25, CRABCares joined more than 200 other teams at the Leukemia and Lymphoma Society's (LLS) Big Climb event at the Columbia Tower in Seattle, WA. The CRABCares team, CRABby Climbers, scaled 69 flights of stairs (1,311 steps) and raised $2,492 for blood cancer research and treatment for patients.
The Leukemia and Lymphoma Society holds Big Climb events annually in cities across the country furthering their mission to cure leukemia, lymphoma, Hodgkin's disease and myeloma, and to improve the quality of life of patients and their families. CRABCares is proud to climb for the LLS mission.
"Events like the Big Climb are fantastic for bringing public awareness to leukemia research, so I wanted to climb this year to do my part for leukemia research fundraising," said Krystle Pagarigan, a CRABby Climbers teammate. "My family was in town visiting from the East Coast and came out to cheer on the CRABby Climbers, and on a whim, my little sister decided to do the timed climb because there was an extra spot for her. It was fun being able to share the experience of climbing the tallest building in Seattle with her!"
For more information on the Big Climb, visit the Leukemia and Lymphoma Society website by clicking here.
CRAB Supports Science Innovation With Presentation at LSINW
On March 27, Tammy Buist gave a presentation on CRAB's capabilities and clinical trial experience at the Life Science Innovation Northwest (LSINW) Conference in Seattle. The annual event is organized by Life Science Washington, an association whose mission to stimulate life science innovation.
The two-day conference, which CRAB finds to be very informative each year, was well-attended and offered several podium presentations and keynote speakers, including a talk by U.S. Senator Patty Murray on the 21st Century Cures Act.
“This was one of our best attended events yet, making CRAB’s two decades of cancer research all the more impactful,” said Ms. Buist. Her presentation highlighted CRAB’s accomplishments, experience and current projects.
Distinguished Scientist and CRAB Collaborator Announces Retirement
Dr. Manuel Valdivieso’s professional career spans almost four decades of clinical investigations ranging from supportive care studies (research on new antimicrobials in cancer patients, studies of intravenous hyperalimentation to minimize chemotherapy toxicities), Phase I clinical pharmacologic studies, and studies of chemotherapy dose response in small cell lung cancer.
Since 1974, Dr. Valdivieso has distinguished himself with academic excellence. A native of Peru, he received his medical degree from San Marcos University Medical School in Lima in 1967. Upon immigrating to the United States, he completed his medical internship, residency, and fellowship in hematology at Cook County Hospital in Chicago, Illinois. In 2000, he obtained his Master’s in Science in Administrative Medicine from the University of Wisconsin. Notably, he has held several tenured faculty appointments. Currently, he is a clinical Professor of Medicine at the University of Michigan Medical School in Ann Arbor, MI. He was a leader, previously, in the Thoracic Oncology Program of the MD Anderson Cancer Center in Houston, Texas and the Karmanos Cancer Institute in Detroit, Michigan, and served as the Head of Hematology Oncology at Wayne State University and Chief Medical Officer at the Karmanos Cancer Institute in Detroit. In addition, he is a member of the National Academy of Medicine in Peru and is an Honorary Member of the Peruvian University Cayetano Heredia. Of his many honors, Dr. Valdivieso has also been named a Best Doctor in America since 2006.
Six years ago, Dr. Valdivieso joined the leadership of SWOG, one of the largest of the National Cancer Institute clinical trial cooperative groups that conducts clinical trials in adult cancers. In his role of Senior Executive Officer for Quality Assurance and International Initiatives, he helped launch the Quality Initiative Committee – composed of physicians, operations office, and statistical office representatives. In his effort to pioneer international partnerships, Dr. Valdivieso helped launch the SWOG Latin America Initiative (SLAI) to ensure that Latin American patients can take part in cancer clinical trials. As a result of these efforts, the national cancer institutes of Mexico, Colombia, and Peru joined SWOG and are actively involved in the Group’s clinical trials with the long-term goal to facilitate the development of an independent Cancer Clinical Research Cooperative Group in Latin America.
As a departure from his prior clinical research interest in lung cancer and phase 1 chemotherapy, Dr. Valdivieso became interested in global health, with a focus on Helicobacter pylori infection and its relationship with gastric carcinoma. He participated in the SWOG study, S0701, of 1400 patients through a three-arm randomized antibiotic trial designed to eradicate h. pylori in seven sites in six countries in Latin America, and separately launched a study of h. pylori in the water supply in Lima, Peru.
“Dr. Valdivieso has been a crucial part of the SWOG effort to improve the state of cancer clinical trials in Latin America, and has been tremendously supportive of CRAB’s work in that regard,” said Dr. John Crowley, CRAB co-founder and current Chief of Strategic Alliances. “He has also been an inspiration to me personally.”
Dr. Valdivieso and other Peruvian physicians founded the Peruvian American Medical Society (PAMS) – a nonprofit organization in the US. Motivated by a passion to help those in need of medical care, Dr. Valdivieso has traveled to Peru on self-funded missions for more than 40 years to provide medications, equipment, training, equipment, supplies, clothing, and computers to Peruvians most desperate and in need.
CRAB is pleased to honor such an extraordinary oncologist, educator, and global health champion. We greatly appreciate his long-standing partnership and shared vision to provide better treatment outcomes to cancer patients around the globe.
Agradiseyki, Dr. Valdivieso!
Spotlight on Clinical Trial Sponsorship" is the focus of SRAI Learning Institute Presentation
Doug Mounce, CRAB’s Grants and Contracts Manager, recently presented a webinar for the Society of Research Administrators International (SRAI) Online Education Learning Institute on clinical trial sponsorship roles and responsibilities for sponsors and investigators. Doug presented on February 28 results from a previously-published paper, "Spotlight on Clinical Trial Sponsorship", which had been presented at an SRAI regional conference in Portland with CRAB’s Chief Business Development Officer Tammy Buist and Board Member Frank Curci. The webinar addressed important FDA regulations to consider when initiating and conducting trials as well as legal principles that have been applied in court decisions on injury claims. Emphasizing the importance of liability and the principles of duty of care, vicarious liability, and fiduciary duty, Doug's presentation drew from Frank Curci’s analysis of court cases where the role of sponsorship impacted the court's decision about particular injury claims.
The SRAI Learning Institute provides an online education program that offers webinars on a wide range of topics related to research administration to support their mission to develop, define and promote international best practices in research management, administration, knowledge transfer and growth of the research enterprise.
"SRAI provided a great opportunity for me to make a CRAB presentation in webinar format to those members of the society who couldn’t attend the conference presentation.” Doug said.
News & Events > Archive
CRAB joins CVAN with other leading life sciences innovators
CRAB and 50 other organizations throughout the Pacific Northwest involved in Life Sciences, Information Technology, and CleanTech Industries convened in Seattle on December 8th, 2017 to sign a memorandum of understanding (MOU) that will establish the Cascadia Venture Acceleration Network.
The Cascadia Venture Acceleration Network is a mandate from the Government of Canada to foster international partnerships in science, technology, and innovation and will focus on the following activities:
“CRAB is pleased to be a founding partner in what will prove to be an important international collaborative effort in the life sciences space,” indicated Tammy Buist, CRAB’s Chief Business Development Officer. “Given our experience in evaluating ‘big data’ derived from clinical trials, we believe strongly that this public private partnership will hasten the reduction in the global burden of cancer.”
Click here for more information on the launch of the Cascadia Venture Acceleration Network.
Mariners Suite Fundraising Event Supports CRAB
Cheers for the Seattle Mariners meant support for CRAB and cancer research during the team's last home stand. CRAB's Board of Directors hosted a fund raiser at a Mariners game against the Oakland Athletics on Saturday, Sept. 2.
A box suite was donated by Merrill Lynch to facilitate CRAB's objective to draw in new donors to support CRAB's mission to play an important role in the fight against cancer. With the support of these donors, CRAB can help patients to live longer and better lives.
Along with seats behind home plate, Merrill Lynch donated tasty ballpark food and arranged a visit from the Mariners Moose. The night was punctuated by an exciting Mariners win, which ended in the bottom of the ninth inning when the winning run scored on a wild pitch with the bases loaded.
"It was a very nice event, thanks to Merrill Lynch, the Mariners and the Moose," Said Keith Goodman, Chief Technology Officer. "The teams at CRAB and Safeco Field have similar goals. The Mariners are working to stay in the playoff race one game at a time and CRAB is working to continue our fight against cancer one clinical trial at a time."
CRAB's Kari Chansky, Dr. Lynn Shemanski, and John Crowley Publish on Validation of Revised Lung Cancer Stage Classification
Kari Chansky, MS, Lynn Shemanski, PhD, and John Crowley, PhD, published an article entitled “The IASLC Lung Cancer Staging Project: External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer” in the July, 2017, edition of the Journal of Thoracic Oncology (JTO).
The article addresses the need for external validation of the IASLC’s staging criteria revisions and why the NCDB was used to evaluate the eighth edition TNM staging criteria. Investigators concluded the NCDB validated the IASLC revisions for the eighth edition of lung cancer staging criteria by the ordering and statistical differences between stage groups and the homogeneity within stage groups, and by the consistency within analyses of specific cohorts.
CRAB and the IASLC have collaborated since the late 1990s and will continue the partnership until at least 2024. The partnership has contributed to staging manuals for lung cancer, pleural mesothelioma, and thymic malignancies as well as the UICC Staging Manual and the seventh and eighth editions of the AJCC Staging Manual.
JTO, the IASLC's premier journal, emphasizes a multidisciplinary approach in the articles and includes original research (clinical trials and translational or basic research), reviews and opinion pieces. In his monthly JTO Editor’s Choice selections, Alex A. Adjei, MD, PhD, Editor-in-Chief, identified the article from Kari, Lynn and John as one of four selected as “articles that highlight certain topics of interest or importance.”
Kari will present the staging project this October at the Pacific Rim Cancer Biostatistics Conference in Kanazawa, Japan.
You can read the full article on the Journal of Thoracic Oncology webpage or by clicking here.
CRAB's President and CEO mentors participants of the ASH Clinical Research Training Institute
The American Society of Hematology’s (ASH) Clinical Research Training Institute (CRTI) is an individualized education and mentoring program for hematology fellows and junior faculty at academic medical centers. It offers education about clinical research methods, research collaborations, statistical analysis, and career advancement by leaders in the field. This program starts with a week-long workshop in La Jolla, CA.
CRAB CEO Antje Hoering, PhD, was invited to serve on the faculty for the 2017 CRTI. In that role she served together with other faculty as mentor for the trainees and helped the participants develop a clinical research project.
“This is a wonderful program that helps kick-start the career of academic hematologists” said Dr. Hoering. “It was inspiring to work with these talented and dedicated fellows and a real privilege to contribute and help them work towards their career goal."
For more information on the American Society of Hematology Clinical Research Training Institute, click here.
Doug Mounce and CRAB Director Frank Curci Publish Article On Clinical Trial Sponsorship. Mounce Also Awarded Scholarship to Give Presentation On Clinical Trial Sponsorship
Doug Mounce, CRAB’s Grants and Contracts Manager, Frank X. Curci, IP partner at Ater Wynne, LLP, and a member of the CRAB Board of Directors, and Joshua B. Fortenbery, intern at Ater Wynne, co-authored a paper entitled “Spotlight on Clinical Trial Sponsorship”. This paper was published by the Society of Research Administrators International (SRAI) in its Journal of Research Administration.
The paper addresses some of the responsibilities and liabilities associated with being the sponsor of a clinical trial. Mr. Mounce, Mr. Curci and the other author of the paper review some of the U.S. Food and Drug Administration’s (FDA) regulations governing the sponsorship of clinical trials as well as certain U.S. court cases which have interpreted the sponsor’s obligations and liability.
You can read the full Press Release about the “Spotlight on Clinical Trial Sponsorship” paper here.
You can read the full “Spotlight on Clinical Trial Sponsorship” paper here.
Mr. Mounce was also awarded a scholarship to attend the Society of Research Administrators International (SRAI) conference held Oct. 22-26, 2016 in San Antonio, where he presented a session on clinical trial sponsorship, and a poster based on the “Spotlight on Clinical Trial Sponsorship" paper. We congratulate him for these achievements.
CRAB Welcomes Curt Malloy
Curt brings tremendous experience to the role. He has led operational activities in Seattle-area non-profit organizations: the Infectious Disease Research Institute, where he served as Senior Vice President of Operations and General Counsel and at the Fred Hutchinson Cancer Research Center, where he served as operations leader of the Vaccine and Infectious Disease Division. Curt is an adjunct professor at Seattle University in the Masters of Public Administration program. He has previously taught courses at the Seattle University School of Law, and the College of Nursing. Curt is a frequent lecturer on global health product development and the role of intellectual property in technology development to reduce the global burden of disease.
Curt is currently board chair for the Washington Global Health Alliance. He is fluent in Spanish, and has worked as a health promoter in Quetzaltenango, Guatemala and as a consultant in occupational epidemiology in Puerto Rico.
CRAB Chief Executive Officer, Antje Hoering, PhD, remarked that she is “very excited that Curt decided to join CRAB. Curt was a board member and friend of CRAB for many years and brings a wealth of experience in life sciences to his new role of Chief Operating Officer.”
Cancer Research Expertise Shared via the SWOG Latin America Initiative
CRAB has been involved in an historic opportunity to learn about cancer research in Latin America, and to share information and collaborate with local researchers. In 2016, Dr. John Crowley, PhD, Chief of Strategic Alliances, and colleagues from SWOG traveled to Mexico City, Lima and Bogota to participate in training activities for SWOG’s Latin America Initiative (SLAI), a program with the goal to foster cancer clinical research infrastructure across the hemisphere. In 2017, the initiative continues with visits planned to Uruguay and Chile in September and Mexico City in November.
Cancer research in Latin America is a focus of activity for SWOG and the National Cancer Institute. The SLAI created an opportunity for CRAB and SWOG investigators to learn about treatment and prevention efforts currently working in Latin America which may be applicable to such efforts in the US, and to gain perspective on what is available for cancer patients and researchers in Latin American countries for clinical trial access and cancer registries.
Last year, many clinical trial professionals in Mexico, Peru, and Colombia received training from SWOG researchers. In Mexico City, about 170 Latin America cancer researchers were exposed to a clinical trials training course that was a vision of Dr. Crowley, who led SWOG’s Statistical Center as Group Statistician from 1984 through 2012. The clinical trial training course covered cancer trial statistical design, information technology, software systems, and data management, and was repeated in Lima and Bogota. About 300 Latin American investigators and research staff attended one or more of these training courses.
Sarah Basse, CRAB Clinical Research Project Manager, said she looks forward to this year’s program and noted that she was inspired by her experience last year.
“It was fascinating to learn firsthand from researchers in Latin America about their experiences fighting cancer in their home countries,” she said. “What I learned was that different geographic, cultural, regulatory, commercial, and scientific environments all contribute to unique challenges in providing compassionate and effective care, and other unique challenges in getting research funded and operationalized. SWOG was able to provide practical advice to fellow researchers, and shared our enthusiasm for cooperating across international borders to achieve successes that benefit all of us, regardless of our nationalities. This underlying message made me incredibly proud to be a member of the SWOG delegation.”
For 2017, efforts will focus on visits to assess institutions in Uruguay and Chile for membership in SWOG, and on putting on a conference in Mexico City with the aim of identifying the cancer burden in Mexico and devising clinical and prevention trials to address that burden.
SLAI began in 2008 under the leadership of former SWOG Group Chair, Dr. Larry Baker, and continues under the leadership of current SWOG Group Chair, Dr. Charles Blanke. Dr. Manuel Valdivieso, M.D., a SWOG executive officer, and Dr. Crowley have developed and supported the program since its inception.
The Latin American Initiative has received generous support from The Hope Foundation which partners with SWOG in support of promising treatments and innovative studies to directly benefit patients.
Access to the Promise of Cancer Research
Cancer control and prevention issues, including multicultural access to prevention methods, medical genetics and access to clinical trials were topics covered at the Cancer Control Thought Leadership Summit at the Swedish Cancer Institute on March 24, 2017. CRAB Co-Founder and Chief of Strategic Alliances, John Crowley, PhD, gave an invited talk to 100 attendees from the local cancer prevention research community for the Research Panel of the event. Dr. Crowley’s presentation was titled “Practicalities of Creating Access to Trials.”
Investigators, health care providers and advocates gathered to share experiences and opportunities in cancer control, across the cancer spectrum from prevention to screening to survivorship. Dr. Crowley remarked that “opportunities for cancer control research were explored, with possibilities for CRAB involvement with local institutions in the future.”
Perspective and Strategy from CRAB on Intellectual Property
New companies often face challenges at the onset of their operations, such as learning to understand intellectual property considerations, licensing technology and how to strategically leverage data management to address these hurdles. CRAB leadership often shares perspective and experiences with regional technology and life sciences industries.
On May 18th, Tammy Buist, CRAB Chief Business Development Officer, gave an invited talk at the Oregon Translational Research and Development Institute (OTRADI) in cooperation with the OTRADI Bioscience Incubator (OBI), PSU Business Accelerator (PSBA), and Ater Wynne LLP. She presented at a Lunch-and-Learn lecture series titled “IP Strategies for Bioscience, Digital Health, and Tech Companies.” CRAB Board Member Frank Curci, Ater Wynn, LLP, serves as the moderator for the series. Ms. Buist’s talk was titled “Data and Know How,” and was held at the OBI.
Excited to participate in this event, Ms. Buist said that this event provided "a unique opportunity for CRAB to share our years of experience in data management as issues surrounding know-how and protecting data as well as sharing data have emerged. The amount of data available and the way that we use it in our understanding of scientific research, and share it to accelerate progress, is one of the most important critical skill sets new companies can possess."
Glassbaby Roadshow Benefits CRAB
As a part of their Road Show series of events in Seattle, Glassybaby recently supported CRAB’s innovations in cancer research via their Mother’s Day Pop-Up Roadshow event at Met Park Seattle. Ten percent of all proceeds, from the in-person event and from online sales between May 10 to May 17, were given to us as a charitable donation.
Event attendees were treated to a rainbow-colored selection of Glassybaby votive products.
Julie Fox, CRAB SAS Programmer, said, “The candle holders were all so pretty, it was tough to choose one.” Roxanne Topacio, Clinical Research Data Operations Supervisor, added, “ I have been fortunate to have been gifted several Glassybaby votives over the years, and I have loved the uniquely original beauty that each casts when holding light. I have always appreciated this local company and their standing philosophy of supporting groups that offer hope and healing. I was thrilled to hear that CRAB would be a recipient organization of their charitable giving.”
News & Events > Archive
CRAB Co-Founder Honored for Influential Research
CRAB Co-Founder John Crowley, PhD, has once again been recognized as most-influential in the field of clinical medicine. Clarivate Analytics has listed Dr. Crowley as one of its Highly Cited Researchers for 2016. This is the second year in which Dr. Crowley has garnered this distinction, which is given to researchers that have a global impact in their respective fields through their published works. Dr. Crowley and the other honored researchers for 2016 are listed on the award’s official website.
Dr. Crowley is the author of more than 400 peer-reviewed professional papers, and has contributed to and edited several books on the methodology of clinical trials, including Handbook of Statistics in Clinical Oncology, Third Edition and Clinical Trials in Oncology, Third Edition. Dr. Crowley’s affiliation with the University of Washington is highlighted with the Clarivate honor. The University thanked Dr. Crowley in their congratulatory letter to him, for his “incredible contributions to the clinical medicine community.”
Doug Mounce Published and Honored by the SRAI
Judicial interpretation of Food and Drug Administration regulations on clinical trial sponsorship in cases of injury claims is the focus of a paper co-authored by Doug Mounce, CRAB’s Grants and Contracts Manager, Frank X. Curci, partner at Ater Wynne, LLP, and a member of the CRAB Board of Directors, and Joshua B. Fortenbery, intern at Ater Wynne. The paper, Spotlight on Clinical Trial Sponsorship, was published by the Society of Research Administrators International (SRAI) in the Spring 2016 issue of their Journal of Research Administration. The authors’ goal for the article was to provide some guidance as to what liability is currently associated with assuming the role of “sponsor” in a clinical trial.
Mr. Mounce was also awarded a scholarship to attend the Society of Research Administrators International (SRAI) conference held Oct. 22-26 in San Antonio where he presented a session on clinical trial sponsorship, and a poster based on the paper. We congratulate him for these achievements.
CRAB Executive Attends State Governor’s Life Sciences Summit
SEATTLE, October 28, 2016 – Tammy Buist, VP and Chief Business Development Officer, represented Cancer Research And Biostatistics (CRAB) at a Life Science Washington event, the 12th Annual Governor’s Life Sciences Summit & Annual Meeting. Ms. Buist stated that this was “an exciting event with great attendance showing a commitment to the Life Sciences sector in Washington State”.
The summit was sponsored by a host of life science organizations from across Washington, and featured presentations on life science industry trends, a talk and question-and-answer session with Governor Jay Inslee, and a panel discussion with state legislators on how Washington might help local life sciences companies flourish and innovate. The history and future of drug development and cancer care was discussed, with cell-based therapies and immunotherapy highlighted as a positive and profound shift in cancer therapy.
Washington Governor Jay Inslee speaking at the 2016 Governor’s Life Sciences Summit. (GeekWire Photo / Clare McGrane)
CRAB CEO a Panelist in Remote Collaboration Discussion
CRAB partnership with Oregon Health & Science University (OHSU) was represented at a panel discussion on remote-collaboration this summer. CRAB President and CEO, Antje Hoering, PhD, served as a panelist for an invited talk titled “Extraordinary Power of Remote Collaboration and Team Science.” The event was the Joint Statistical Meeting (JSM) in Chicago, held in August.
Topics of the discussion included critical factors of successful collaboration (building trust, shared vision and recognition, conflict resolution) and exploration of what makes remote, multi-disciplined scientific research teams healthy and productive. Antje Hoering from CRAB, and Motomo Mori, director of the Biostatistics Shared Resource at the OHSU Knight Cancer Institute, were selected as panelists due to their success in remote-team collaboration; they helped describe how statisticians can be effective leaders and facilitators for such teams.
CRAB CEO a Panelist in Blood Cancer Clinical Trials Discussion
Innovation in medicine and addressing unmet medical needs in the face of life-threatening illnesses were elements of a public meeting that CRAB attended this year. CRAB President and CEO, Antje Hoering, PhD, served as a panelist in the discussion titled “Minimal Residual Disease as a Surrogate Endpoint in Hematologic Cancer Trials.” The day-long meeting was held in Washington, DC in September. The chief topic was the use of minimal residual disease (MRD) as a surrogate endpoint in clinical trials for blood cancers.
The discussion covered the regulatory background, statistical basis and evidence to support the use of MRD as a surrogate endpoint in clinical trials for new treatments of acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, and multiple myeloma. Dr. Hoering spoke as a statistician on the myeloma panel at the event.
CRAB Strode with PurpleStride Puget Sound 2016
On Sunday, October 30, 2016, employees, colleagues, family and friends of Cancer Research And Biostatistics (CRAB) united for the fourth consecutive year to support awareness and research for pancreatic cancer. CRABCares, the CRAB public-outreach committee, participated in the 2016 PurpleStride Puget Sound event at Magnuson Park in Seattle. CRAB staff, along with friends and family members, showed support for the larger Seattle community of survivors, researchers and awareness activists as they strode in this 5K fun-run/walk, to share stories, smiles and conversation.
Each year, in communities across the US, tens of thousands of people participate in more than 56 PurpleStride events. These events are critical in raising awareness and funds that advance research and support patients and loved ones with a promise of a better tomorrow. One of CRAB's key research partnerships, the Pancreatic Cancer Research Team (PCRT), has member-sites across the US that participate in PurpleStride events throughout each year.
John Crowley, co-Founder and Chief of Strategic Alliances at CRAB, pledged to support PurpleStride Puget Sound this year: "CRAB is proud to stride with PanCAN in support of our shared mission to help conquer pancreatic cancer. This effort is very important to me, personally and professionally. Therefore, I have pledged to match every dollar raised by the CRABCares team for PanCAN through this event with a dollar to CRAB in support of the PCRT."
CRAB Treads with PurpleStride Puget Sound 2016
On Sunday, October 30, 2016, employees, colleagues, family and friends of Cancer Research And Biostatistics (CRAB) unite for the fourth consecutive year to support awareness and research for pancreatic cancer. CRABCares, the CRAB public-outreach committee, will participate in the 2016 PurpleStride Puget Sound event at Magnuson Park in Seattle. CRAB staff, along with friends and family members, will show support for the larger Seattle community of survivors, researchers and awareness activists as they stride in this 5K fun-run/walk, to share stories, smiles and conversation.
Each year, in communities across the US, tens of thousands of people participate in more than 56 PurpleStride events. These events are critical in raising awareness and funds that advance research and support patients and loved ones with a promise of a better tomorrow. One of CRAB's key research partnerships, the Pancreatic Cancer Research Team (PCRT), has member-sites across the US that participate in PurpleStride events throughout each year.
John Crowley, co-Founder and Chief of Strategic Alliances at CRAB, has pledged to support PurpleStride Puget Sound this year: "CRAB is proud to stride with PanCAN in support of our shared mission to help conquer pancreatic cancer. This effort is very important to me, personally and professionally. Therefore, I have pledged to match every dollar raised by the CRABCares team for PanCAN through this event with a dollar to CRAB in support of the PCRT."
We encourage you to join us. You can visit the CRABCares team site to register, make a donation or to learn more about PurpleStride Puget Sound - http://support.pancan.org/site/TR/PurpleStride/PurpleStride?team_id=2140&pg=team&fr_id=1151.
CRAB Host to the Young Investigators, September 26-28, 2016
The annual SWOG Young Investigators conference was hosted by CRAB September 26th through 28th. The conference featured SWOG leadership members, CRAB data managers and six investigators who were introduced to SWOG protocol development, maintenance, and administration. We say thank you to this year's group:
Uma M. Borate, MD, MS
Virginia Sun, RN, PhD
Erin F. Cobain, MD
Cecilia C.S. Yeung, MD
Kristen M. O'Dwyer, MD
Emma C. Scott, MD
CRAB Mourns Loss of Valued Friend and Supporter
It is with great sadness that we inform you of the passing of longtime CRAB friend – Roy Powell, on August 9.
An accomplished artist and custom home builder, Roy Powell left beauty behind in the form of his free standing steel sculptures, original furniture design, ceramics and homes.
His work can be seen throughout Washington, Oregon and the Sacramento, CA areas. A native of Southern California, Roy attended the University of Redlands and received a master’s degree in teaching from nearby Chico State College. Prior to embarking on a home building and renovating career, Roy was a valued high school educator in the Madeira, CA area for nine years.
Roy was diagnosed with glioblastoma in early 2015 and underwent two surgeries and chemotherapy and radiation therapy to remove the brain tumors. After his year and a half fight against this aggressive cancer, Roy died peacefully in his sleep on August 9.
His passing is an incredible loss and he is greatly mourned by his numerous friends, family and all who knew him. Roy is survived by his wife, Ruth Crowley, and brother-in-law and CRAB co-founder, John Crowley.
CRAB extends its heartfelt condolences to Roy Powell’s family at this time along with our deepest appreciation for his support of our work.
John Crowley Inducted as a Fellow of the Society for Clinical Trials
John Crowley, PhD, has been inducted as a Fellow of the Society for Clinical Trials (SCT), a scientific organization that advocates for the use of optimal methods and practices in clinical trials. Dr. Crowley, CRAB’s co-founder and Chief of Strategic Alliances, received the honor in May during the SCT’s 37th Annual Meeting in Montreal.
The SCT inducted Dr. Crowley for his “…important contributions to survival analysis and to the statistical methodology for the design and analysis of cancer clinical trials; for leadership in clinical trial coordination and conduct through SWOG, a national cancer clinical trials consortium; for key roles in clinical trials that advanced outcomes for patients with myeloma, lung cancer and pancreatic cancer; and for contributions to the education and training of clinicians and statisticians in the methods of cancer clinical trials.”
Created in 1978, the SCT is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct, and analysis of government and industry-sponsored clinical trials and related health care research methodologies. The Society established the title of “Fellow of the Society for Clinical Trials” in 2005, to honor society members who have made significant contributions to the advancement of clinical trials and to the society. With the Fellow honor, Dr. Crowley joins a very distinguished international group of physicians, clinicians and researchers from many scientific disciplines.
CRAB's First Fully-Validated Registration Trial May Change Standard-of-Care for AML Patients
Cancer Research And Biostatistics (CRAB), a non-profit organization whose mission is to help conquer cancer through application of biostatistical principles and data management methods, reached a milestone in early 2016. CRAB successfully completed a fully-validated registration clinical trial with Celator Pharmaceuticals that yielded significant, positive results for patients with high-risk acute myeloid leukemia (AML). With this project, CRAB demonstrates its capacity and talent to run Phase III registration trials, which is a notable achievement for the organization.
Jazz Pharmaceuticals (formerly, Celator), whose mission is to extend and improve the lives of cancer patients through innovation in combination therapy, announced improvement in overall survival and induction response rate in the Phase III trial for VYXEOS™ (CPX-351) in patients with AML.
Patients with high-risk AML were randomized to receive current standard of care (7+3) or CPX-351 (cytarabine: daunorubicin, Liposome for Injection). Patients in the CPX-351 arm had a significantly longer median overall survival time (9.56 months) compared to patients randomized to the standard therapy group (5.95 months) (HR=0.69, p=0.005).
With a 12-person team, CRAB provided electronic data capture, data management and statistical analysis for this Phase III clinical trial. CRAB’s team included biostatisticians, program and project managers, regulatory and quality assurance managers, data managers, application developers, and project specialists.
“This has been a true team effort and a steep learning curve for all of us at CRAB,” said CRAB CEO Antje Hoering, PhD. “It is most exciting for the AML patient for whom little progress in treatment has been made in many years. This study may change standard of care for these patients. It is also a real milestone for CRAB as this is our first registration trial with all its regulatory requirements.”
CRAB’s CEO recently accompanied the trial sponsor to Washington, DC for a pre-New Drug Application meeting for VYXEOS™ (CPX-351) to the Food and Drug Administration.
The results of this clinical trial are exciting developments for CRAB as it continues its mission to conquer cancer, and, most importantly, for AML patients for whom there has been limited progress in the development of treatments.
For more information about the VYXEOS™ (CPX-351) registration trial, please visit Celator’s press release via this link.
Updated 01 Jul 2019
CRAB Presented at 2016 SRA International Western/Midwest Section Meeting
Doug Mounce, Grants & Contracts Manager, Tammy Buist, Chief Business Development Officer, and Frank X. Curci JD, Ater Wynne LLP, CRAB Board Member, presented at the 2016 Western/Midwest Section Meeting of the Society of Research Administrators (SRA International) at 9:00 AM on Wednesday, May 18, 2016 at the Portland Marriott Downtown Waterfront. The presentation title is W106: Spotlight on Clinical Trials.
There is a natural concern with the responsibility implied by assuming the role of “sponsor” in a clinical trial agreement. In addition, the investigator is the sponsor for Investigator Sponsored Trials (ISTs, sometimes called Investigator Initiated Trials or IITs - the type of trials that CRAB often manages for the Clinical Trials Consortium). This presentation gave an overview on (1) Navigating the Waters of Clinical Trials, (2) Rules and Regulations that Impact Institutional Policies and Procedures, and (3) Legal Considerations that Impact Clinical Trial Sponsorship.
SWOG Myeloma Trial Therapy Lengthens
Time Before Reoccurrence and Life
At the 57th annual meeting of ASH, the American Society of Hematology, on Dec. 5, 2015, SWOG presented exciting results from the S0777 clinical trial on myeloma that may indicate a new standard of care for this disease.
S0777 is a Phase III clinical trial in front-line Multiple Myeloma which enrolled 471 eligible and analyzable adult patients, ages 28 to 87, between February 2008 and February 2012 at institutions of the National Cancer Institute National Cancer Trials Network. Patients were randomized to two treatment groups. One group received standard first-line treatment of lenalidomide and dexamethasone while the other group received lenalidomide and dexamethasone combined with bortezomib, a drug that is typically given as a second-line therapy to patients whose cancer progresses. At ASH, SWOG researchers revealed that patients in the three drug arm that included bortezomib had a median remission time of 43 months compared to 30 months in the two drug arm and lived a median of 75 months compared to 64 months in the arm with only lenalidomide and dexamethasone.
CRAB contributed to this trial with statistical, data management, and technology support as a member of the SWOG Statistical and Data Management Center housed at the Fred Hutchinson Cancer Research Center and CRAB.
For more information on the results, please read SWOG’s press release here: S0777PressRelease.pdf.
CRAB Hosts Training Event in Clinical Trial Design
Cytel will host a one-day training seminar at CRAB on Monday, April 11, 2016 on the topic of Applying Advanced Methods in Clinical Trial Design. To register for this event and to learn more about it, please click the "Register Now" button below.
News & Events > Archive
Cancer Will Be The No. 1 Killer In The US
Cancer is a major health problem and is currently the second leading cause of death in the United States. It is expected to surpass heart disease as the leading cause of death in the US soon. As the sobering statistics reveal, funding cancer research is more of a priority than ever. Access the statistics from the American Cancer Society here: http://bit.ly/1PPV2A0
December 10 -13: Make a Difference with Art
CRAB Founder Gives Presentation at OHSU
On December 9th, our founder, John Crowley, Ph.D., will give an invited presentation at the Oregon Health Science and University (OHSU) titled "Some Thoughts on Informatics and Reproducible Cancer Research". The talk is open to the public and designed for an audience of basic and applied scientists, students and professionals in healthcare. The presentation will describe integration of basic science investigations with clinical care and the conduct of clinical trials. For on-site location information and more details about the event please visit the Knight Cancer Institute website (link).
Make Cancer Research a Priority on December 1
CRAB Founder Gave Keynote at Vanderbilt University
On October 13, 2015, CRAB's Chief of Strategic Alliances, John Crowley, PhD., gave an invited keynote talk at the Vanderbilt Center for Qualitative Sciences' 2015 CQS Fall Retreat for their faculty, staff and trainees. The audience for the talk was an interdisciplinary group of Vanderbilt scientists from fields with a quantitative focus, including biostatistics, bioinformatics, biomathematics, systems biology, computational biology, statistical genetics and epidemiology. The talk was conceived to foster familiarity and collaboration among these groups.
Dr. Crowley's keynote talk was titled "Through The Looking Glass: Some Thoughts on Quantitative Science and Interdisciplinary Research". Dr. Crowley noted that "this was a great opportunity to showcase CRAB's contributions to clinical and translational cancer research for a distinguished group of scientists."
CRAB In-Step with Pancreatic Cancer Awareness
Employees, colleagues, family and friends of Cancer Research And Biostatistics (CRAB) joined together on Sunday, November 1, 2015 to support awareness and research for pancreatic cancer. CRABCares, the CRAB public-outreach committee, participated in the 2015 PurpleStride Puget Sound event at Magnuson Park in Seattle. CRABCares members strode in this 5K fun-run/walk, sharing stories, smiles and conversation with the larger community of survivors, researchers and awareness activists.
Each year, in communities across the US, tens of thousands of people participate in more than fifty-six PurpleStride events. These events are critical in raising awareness and funds that advance research and support patients and loved ones with a promise of a better tomorrow. One of CRAB's key research partnerships, the Pancreatic Cancer Research Team (PCRT), has member-sites across the US that participate in PurpleStride events throughout each year.
We hope you had a great time at the event!
CRAB’s Impact at International Association for the Study of Lung Cancer Research Conference
On September 5th, 2015, CRAB scientists attended the meeting of the IASLC Staging and Prognostic Factors Committee at the IASLC 16th World Conference on Lung Cancer. John Crowley, Lynn Shemanski, Kari Chansky, Alan Mitchell and Vanessa Bolejack represented CRAB at this event, where proposals for revising the staging systems for lung cancer and mesothelioma were reviewed.
The 8th revision of the staging system for lung cancer was later presented at the event’s plenary session. CRAB’s expertise was highlighted as a statistics and data center. The 8th revision of the staging system for mesothelioma was also presented. “It is very gratifying to see our work over the past seven years being presented to this international audience,” noted Dr. Crowley. If approved by the American Joint Committee on Cancer and the Union Internationale Contre le Cancer, the new staging systems will be implemented in January of 2017.
Also at the meeting, Suzanne Arnold, MD. of the University of Kentucky presented a poster describing the phase I results for the CRAB Lung Cancer Research Team trial 11-001, IASLC 241.
CRAB Hosts Young Investigators Conference
The annual SWOG Young Investigators conference was hosted by CRAB September 9th through 11th, 2015. The conference featured SWOG leadership members, CRAB data managers and six investigators who were introduced to the ways and means of SWOG protocol development, maintenance and administration.
For more details about the event please visit the SWOG website:
CRAB Stages Important Cancer Biostatistics Conference
On August 14 and 15, the first Pacific Rim Cancer Biostatistics Conference took place at the historically-designated Washington Athletic Club (WAC) in Seattle, Washington.
With the generous support of our sponsors - the Institute of Statistical Mathematics (ISM) and Kakenhi (Japan Society for the Promotion of Science: Grants-in Aid for Scientific Research), we brought together well-renowned statisticians in oncology research to collectively share breakthroughs, foster innovation, and advance statistical methods to conquer cancer.
The two-day event was well attended by Statisticians, Professors of Biostatistics, and oncology research professionals with an international group of twenty highly-regarded speakers presenting on cutting edge sessions in the areas of clinical and translational research in oncology, prognostic analysis and risk prediction, predictive modeling and performance assessment, screening/epidemiology, and analysis of genomic/imaging data. The group even braved the rain and Seahawks game traffic to attend a post-conference dinner!
We thank our sponsors, presenters, partners and attendees for their partnership and participation and for helping to make the inaugural Pacific Rim Cancer Biostatistics Conference a tremendous success.
CRAB, Berg and BIDMC Align with PurpleStride Boston 2015
Berg Biosystems and Beth Israel Deaconess Medical Center (BIDMC) joined forces to fight pancreatic cancer at Purple Stride on Sunday, August 16, 2015 at Boston Common. BIDMC served as honorary chair of the Pancreatic Cancer Action Network (PanCAN) for the day. BIDMC set up a tent at Purple Stride Boston to represent its joint-mission with PanCAN, promote BIDMC clinical services, and build buzz around Project Survival in the community most affected by pancreatic cancer.
The event increased visibility of Project Survival, a multi-institutional collaboration targeted at pancreatic cancer to discover breakthrough diagnostics and allow for development of targeted treatments against pancreatic cancer. To learn more about Project Survival please visit this link: http://bit.ly/1GSJwA5. Niven Narain, CEO of Berg Biosystems, discusses Project Survival in this Fox Business Interview on YouTube: https://youtu.be/FhnTsgJK9W8.
CRAB Aligned with Lung Cancer Awareness Group
CRAB joined with the "Community of Hope" - aligning our mission to help fight and raise awareness of lung cancer. On Saturday, August 8th 2015, CRAB's outreach committee, CRABCares, participated in the Breathe Deep Seattle fun-run/walk at Seward Park. The event was hosted by Lungevity. CRABCares members, their families and their friends enjoyed conversation, coffee and interactions with the greater lung cancer survivorship community. Smiles and stories were shared by attendees.
CRAB and Berg Honor Cancer Survivors at Fenway Park
July 10, 2015 - Researchers from Cancer Research And Biostatistics (CRAB), Berg Biosystems and Beth Israel Deaconess Memorial Hospital recognized cancer survivors at a Red Sox vs Yankees game at Fenway Park. CRAB researchers John Crowley, PhD and Amy Stoll-D’Astice, Dr. Ramesh Ramanathan, MD along with Dr. Jim Moser, MD from BIDMC and Niven Narain, CEO of Berg, gathered in Boston for a weekend meeting at Berg’s offices to discuss Project Survival, Berg’s multi-institutional initiative in pancreatic cancer targeted therapies. Amy Stoll-D'Astice called the Fenway Park event "a wonderful recognition of Pancreatic Cancer survivors with a team hoping to “hit it out of the ballpark” with Project Survival". Read more about Project Survival at this link: http://bit.ly/1GSJwA5.
Pancreatic Cancer Biomarker the Goal of “Project Survival”
SEATTLE, June 18, 2015 – Cancer Research And Biostatistics (CRAB) is working through our Pancreatic Cancer Research Team (PCRT) network on "Project Survival," a multi-institutional collaboration targeted at pancreatic cancer to discover breakthrough diagnostics and allow for development of targeted treatments against pancreatic cancer. CRAB and the PCRT network provide the essential infrastructure and expertise for a project with these lofty goals. You can view an interview with Niven Narain, CEO of Berg, with Diedre Bolton of Fox Business on her Risk & Reward show at this link: https://youtu.be/FhnTsgJK9W8.
More information about the project can be found here: http://bit.ly/1GSJwA5.
If you are interested in supporting cancer research please consider a donation to CRAB, a 5013c non-profit research institute. Click here to donate: donate.html
CRAB Presented at 2015 Life Science Innovation Northwest
SEATTLE, June 17, 2015 – Tammy Buist, VP and Chief Business Development Officer, represented Cancer Research And Biostatistics (CRAB) and gave a podium presentation at the Life Science Innovation Northwest exposition (LSINW). The event was hosted by the Washington Biotechnology & Biomedical Association (WBBA). Ms. Bust described CRAB's impact on cancer using innovative partnerships and alliances, including the Pacific Rim Cancer Biostatistics Conference that CRAB will host in August and Lung and Pancreatic Cancer clinical trials run through CRAB's clinical trials consortia.
Ms. Bust's presentation was on June 30, 2015, at 2:10 PM in the Innovation section of the conference.
Berg President Interview on A.I. in Healthcare and 'Project Survival'
BOSTON, June 11, 2015 – Berg President and CTO Niven Narain gave an interview with Fox Business News on Project Survival and the use of artificial intelligence and big data in their work with pancreatic cancer. Watch the full interview on YouTube.
CRAB Founder Speaks at the SCT Annual Meeting and a Memorial to Marvin Zelen
John Crowley, PhD and Chief of Strategic Alliances at Cancer Research And Biostatistics (CRAB), will participate in a session at the Society for Clinical Trials (SCT) Annual Meeting on May 18, 2015. The session, titled "Recipe to becoming a successful biostatistician in a collaborative environment", will focus on successful career development and leadership. Mentoring, communication and project management strategies will be discussed by Dr. Crowley and a panel of three other speakers.
Dr. Crowley will also give an invited talk at the SCT's memorial session for Dr. Marvin Zelen. Dr. Crowley will discuss Dr. Zelen's contributions to cancer clinical trials and his influence on Dr. Crowley's own work.
John Crowley is the Founder and until 2014 the Chief Executive Officer of CRAB, a nonprofit research organization dedicated to helping conquer cancer. He received his PhD in Biomathematics from the University of Washington, and has had faculty appointments at the University of Wisconsin, the University of Washington and the Fred Hutchinson Cancer Research Center.
Co-founder Dr. Catherine Crowley Moves on to “Other Duties”
CRAB co-founder Dr. Catherine Crowley has decided to pursue a new chapter in her life. After 16 years in leadership, Cay retired from CRAB at the end of December.
Dr. Cay Crowley joined her husband, Dr. John Crowley, in founding CRAB in 1997 as the home of the data management component of the SWOG Statistical Center, with a mission to help conquer cancer and other diseases using biostatistical principles and innovative data management methods. Cay became the original employee when CRAB’s first office opened in the Crowley’s basement in 1999. Sixteen years later, CRAB is a well-known research organization with more than 80 employees.
Over the years, Cay has served several administrative roles at CRAB. Having a doctorate in Developmental Psychology from the University of Washington served Cay well in taking on the many challenges that are a part of building an effective organization. After completing postdoctoral training in clinical psychology at University of Wisconsin, Cay practiced in Wisconsin before moving to Seattle where she co-founded Northwest Psychological Services. Cay says that her training and business experience provided her with many of the skills she has used at CRAB.
Serving over the years as Chief Administrative Officer, Chief Operations Officer, and Chief Financial Officer, Cay performed the usual tasks associated with the titles and many others that fall under “other duties, as assigned,” always included in her job descriptions. Cay led the development of sound administrative, financial, and human resources policies and procedures. Regulations don’t always make it easy to produce policies that are consistent with making CRAB a great place to work, but Cay worked diligently to strike a balance. Recently, Cay completed comprehensive revisions to our policies and procedures, and was instrumental in the design of the SharePoint site where the documents are now stored.
For many years, Cay was responsible for the development and maintenance of CRAB's strategic plan. As a corporate officer, Cay served as a CRAB Vice President, with Board-defined roles as Secretary and Treasurer, and she spent many years as the primary liaison with the Board of Directors. Cay was also CRAB’s chief Annual Report and newsletter writer.
Cay’s financial stewardship has been demonstrated in the development of an excellent Finance team who follow sound policies and procedures that have consistently resulted in clean audits and accurate budgeting, and in the development of a reserve fund and the creation of a rich benefit package for employees.
Included among Cay’s roles is the acquisition of office space, facilities, and equipment to meet the technology needs associated with biostatistical analyses. In 2007, Cay led an effort to obtain support for a high dimensional genomic and proteomic data to support cancer biology research and clinical trials. Support to purchase the system of servers and disk storage came from the Myeloma Institute for Research and Therapy (MIRT), MJ Murdock Charitable Trust, and the Seattle Foundation.
CRAB has grown over the years and Cay has overseen moves from the Crowley basement to the Metropolitan Park West building in downtown Seattle and across the street to the Metropolitan Park East building. In 2009, Cay completed negotiations on an affordable 10-year lease. In 2010, Cay had oversight of a remodel of the two floors that CRAB occupies, including all new network cabling, functional meeting spaces, and a modern computer data center with a cooling system independent of the building’s system, a new power supply with battery backup, and a sprinkler system that is charged with water only in the event of a fire. The new lease ensures that CRAB remains at Met Park East into April, 2020.
Throughout her career Cay has been the consummate team player, providing support for many collaborative efforts to implement John Crowley’s vision to form CRAB into a leading cancer research center. Cay’s financial management, administrative oversight, and organizational efforts supported the work of many at CRAB in the accomplishment of important projects.
Chief Executive Officer Dr. John Crowley, making his own transition in 2015 to Chief of Strategic Alliances, said, “Cay’s many contributions have been vital to CRAB’s growth as an effective research organization. I wouldn’t have started CRAB if I wasn’t sure that I could trust Cay to do whatever was required for us to succeed as an organization.”
As CRAB’s co-founder, Cay will continue to contribute through her legacy and support. Supplied with a permanent key card to CRAB offices, she will continue to be sought out for advice when she’s in the building. Cay’s next job description isn’t written yet, but it’s sure to include new challenges and adventures and the quintessential other duties, as assigned, with one important distinction. For her new job description, Cay said, “I’ll be the one assigning the other duties.”
CRAB Scientists Presented at Clinical Trials Training Course
Antje Hoering and John Crowley presented at a training workshop in integrative oncology research hosted by Cancer Treatment Centers of America CTCA at the Western Regional Medical Center in Phoenix, AZ on Friday and Saturday, April 24-25, 2015. Drs. Hoering and Crowley gave talks on Phase I and II clinical trials and help with protocol development and related statistical considerations.
CRAB has collaborated with CTCA since 2013 on training workshops. John and Antje are proud to continue this work with CTCA.
CRAB Networks with Survivors
March 31, 2015 -- CRAB continues to engage with the local community of cancer survivors and patient allies. CRAB was honored to host presentations on cancer survivorship and patient advocacy, given by Anna Gottlieb, Director of Gilda's Club Seattle and two survivors: Ann Collier, RN and her daughter Katie Collier, a University of Washington Junior and Huskies Women's Basketball player. Ann and Katie shared her story of surviving breast cancer and Katie is a survivor of leukemia. The event, attended by CRAB employees and Board of Directors members, featured information on CRAB's plans to create a survivorship website in collaboration with SWOG.
Lunch, smiles and a few tears were shared. Larry Kaye (Data Coordinator) called Ann and Katie "extraordinary cancer survivors, truly inspirational...[their story] makes me proud to work in non-profit cancer research". Pingping Qu (Senior Biostatistician) said "it was a great session...I admit I had to use some kleenex myself". Grace Powell (Regulatory Affairs/QA Manager) called the event "another reminder of why we do what we do!"
Help Us Win The Game Against Cancer
Today, CRAB is participating in the Seattle Foundation’s GiveBig – Day of Champions.
What is GiveBig?
The Seattle Foundation’s GiveBIG is a one-day, online charitable giving event to inspire people to give generously to nonprofit organizations, such as CRAB, to make our region a healthier and more vital place to live.
Join CRAB’s Circle of Champions today!
Why Not Make a Direct Donation to CRAB instead?
Your direct contributions to CRAB are always welcome and greatly appreciated!
On May 5th, - From midnight to midnight - we’re asking our friends and supporters to make a donation to CRAB via the Seattle Foundation’s website. Every donation to CRAB will receive a prorated portion of the matching funds (or “stretch”) pool. The amount of the “stretch” depends on the size of the total stretch pool and how much is raised in total donations on GiveBIG day.
Doesn’t matter if you give a dollar or $1,000
Every contribution makes you a CRAB M.V.P.
Help us win the game against cancer – join our Circle of Champions on May 5!
To find out how your tax-deductible donations to CRAB impact cancer research and cancer treatment outcomes, please visit CRAB.org or email us at
To learn more about GiveBig and the Seattle Foundation, visit http://www.seattlefoundation.org/.
CRAB at the SWOG Group Meeting This Week
CRAB colleagues will attend and participate in the Spring 2015 SWOG Group Meeting in San Francisco this week, April 29 through May 2. CRAB staff will facilitate the Clinical Trials Training Course for new CRAs, answering questions and sharing expertise in clinical trial data management.
CRAB will also facilitate presentations and activities for the SWOG prevention study PACES (SWOG study S0820 - Preventing Adenoma of the Colon with Eflornithine & Sulindac) on April 30th. There are over 300 SWOG institutions and 200+ non-SWOG institution’s participating in the study.
SWOG’s Social Media Working Group will bring the founder of TheMedNet and the Executive Director of The Survivor Games to networking events at the Group Meeting, highlighting efforts to connect cancer survivors with each other. Plenary session topics will include proteomics and efforts to “go global” with SWOG trials.
CANCER - The Emperor of All Maladies
Based on the 2010 Pulitzer Prize-winning book by Siddhartha Mukherjee, this three-part, six-hour documentary is one you will not want to miss.
CRAB at Seattle's Big Climb 2015
CRABCares, the community outreach arm of CRAB, supported lymphoma and leukemia research on Sunday, March 22, 2015 by joining cancer survivors, families and friends in the Big Climb. The team CRABBY CLIMBERS scaled the 69 flights of stairs with the larger community of survivors, family and friends. Several CRAB climbers finished in less than 14 minutes!
This event marked CRAB's third appearance at the inspirational event. If you marched in the event we hope you had fun! Watch this space for more of future CRABCares events.
News & Events > Archive
Shop at Fred Meyer and raise money for CRAB
Through its Community Rewards program, Fred Meyer is giving away $625,000 to nonprofits each quarter in 2014.
Enroll online and link your Rewards Card to CRAB by visiting Fred Meyer Community Rewards. Don't worry; you'll still receive all Rewards Card perks. You'll just also raise money for CRAB every time you shop and use your Rewards Card!
So be sure to link your rewards card to CRAB, and the next time you shop at Fred Meyer, know you are helping support cancer research.
PurpleStride 2014: Pasta and Participation
Members of CRABCares, CRAB colleagues and their familes joined together over the past week, at CRAB and at Magnusson Park in Seattle's Sand Point neighborhood, to support CRABCares' participation in PurpleStride 2014. Much support and merriment was shared to benefit pancreatic cancer research.
The CRABCares pasta potluck on October 30th featured the cooking talents of CRAB employees who dazzled diners with baked ziti, spaghetti and quinoa noodles, among other dishes. Raffle prizes were won and smiles were spotted. On November 2nd colleagues gathered under CRAB's canopy at PurpleStride 2014 to share cocoa, doughnuts, run/walk strategies and cheers.
CRAB Presents at CANSSI in Toronto
Dr. Antje Hoering presented at the Workshop on Statistical Issues in Biomarker and Drug Co-development. The workshop was held in Toronto and sponsored by CANSSI, the Canadian Statistical Sciences Institute.
The 1.5-day workshop on biomarker and drug co-development focused on education of researchers about emerging developments in statistical designs and analyses for clinical trials and translational research, as well as to identify open statistical problems for which attendees will consider organizing research proposals. International experts provided an introduction to biomarker data and an overview of current design, analysis, and reporting principles with issues for research. Workshop participants solidified their knowledge about the current state of the field(s); networked, identified knowledge gaps and to proposed research initiatives that will be the focus of a full grant application which will globally enhance and expedite biomarker research.
For more details about the workshop please visit its website at http://www.fields.utoronto.ca/programs/scientific/14-15/biomarker/.
Thank You Government Employees
Cancer Research And Biostatistics (CRAB) would like to thank all of the employees of King County government and the federal and military personnel who support our work through employee giving programs in 2014.
CRAB is focused on people, people you may know – people with underfunded and under-researched cancers, the ones we can’t yet routinely cure, such as myeloma, pancreatic and lung cancers.
Today, these three cancers alone take more than 209,000 lives a year in the United States.
Thank you for helping us reduce these numbers!
In the last year along, CRAB helped bring new choices to patients – one of these could be the one that makes a difference.
With your generous contributions, we can build upon these successes to provide more treatment options to event more cancer patients, sooner.
Thank you for your support and we look forward to partnering with you again in 2015!
Pancreatic Cancer Research at CRAB Receives Support from Northwest Artist
Lampwork bead artist, Valerie Coxon, RN, PhD, owner of AnnieAlta, will donate the sale of three necklaces to support pancreatic cancer research at CRAB when she participates in Purple Friday Weekend, a fine arts and craft show. The event will be held Nov. 28 to 30 (Noon to 6 pm) at the Ryan James Fine Arts gallery located at 11905 124th Ave NE in Kirkland. Her gift to CRAB is inspired to help pancreatic cancer research and to honor the recent passing of a friend of the Ryan James gallery, Stephen Hal Mohlman, following his battle with pancreatic cancer.
Please read the full story about NW Artist’s Purple Donation.
CRAB Teaching Abroad
Drs. Antje Hoering and John Crowley taught at the "Statistics in Clinical Oncology" workshop in Brussels on October 9-10, 2014.
The purpose of the workshop was to discuss fundamental concepts of oncology clinical trials and to provide real-world examples of such trials using CRAB's online tools and calculators. Drs. Hoering and Crowley were invited as instructors for the workshop as renowned statisticians and data scientists.
The conference was attended by twelve participants with medical backgrounds from various drug companies. Dr. Hoering was happy to note that "everyone was very interested, asked many questions and we had lively discussions. We taught how to use the tools on our [Resources] web page. They loved those and said they would show their colleagues. It was great for creating buzz for CRAB."
CRAB Scientists Teach Brussels Statistics Workshop
Drs. John Crowley and Antje Hoering will teach the "Statistics in Clinical Oncology" workshop in Brussels, October 9-10, 2014. The event will feature two day-long modules that cover the following topics:
Module 1: Phase I and II Oncology Clinical Trials
Topics in early phases of oncology clinical trials (phase I-II) will be covered. Real world examples of recent SWOG and CRAB clinical trials will be given and trial designs will be demonstrated using CRAB's on-line calculators. The first half of the course will review basic concepts of oncology clinical trials including safety, efficacy and endpoint considerations. The most common phase I trial designs will be discussed. Single stage, two-stage phase II trial designs and randomized phase II trial designs, as well as pros and cons of these designs in various clinical settings, will be covered. The third edition of the Handbook of Statistics in Clinical Oncology edited by the instructors was published in the summer of 2012. The second half of the course will cover current topics in phase II oncology clinical trial designs based on this Handbook, including trial designs for cytostatic or targeted agents. Variations with targeted agents include dose exploration in seamless phase I/II trials; multiple strata phase II trials.
Module 2: Phase III Oncology Clinical Trials
Topics in phase III oncology clinical trials will be covered. Superiority and non-inferiority oncology phase III trials as well as DSMC issues will be reviewed. Real world examples of recent SWOG and CRAB clinical trials will be given and trial designs will be demonstrated using CRAB's on-line calculators. The third edition of the Handbook of Statistics in Clinical Oncology, edited by Drs. Crowley and Hoering, was published in the summer of 2012. The second half of the course will cover current topics in phase III oncology clinical trial designs based on this Handbook, including trial designs for cytostatic or targeted agents. Variations with targeted agents include phase II/III trials; and phase III designs for joint biomarker and drug development.
For more details about the event please visit the website:
CRAB Hosts Young Investigators Conference
The annual SWOG Young Investigators conference was hosted by CRAB September 29th through October 1st. The conference featured SWOG leadership members, CRAB data managers and six investigators who were introduced to the ways and means of SWOG protocol development, maintenance and administration.
For more details about the event please visit the SWOG website:
The CRAB 2013 Annual Report was designed and produced by the talented design team of Moe Abbott and Minhye Kim – student graphic designers from the Art Institute of Seattle. Selected from eight competing students, the winning design concept uniquely showcases CRAB’s impact and progress in the areas of lung and pancreatic cancers and myeloma and leukemia research.
We hope you enjoy reading CRAB’s 2013 Annual Report and learning more about our groundbreaking work.
CRAB CSO Antje Hoering, PhD., served as the Chair and Organizer of an invited session at the 27th International Biometric Conference (IBC) in Florence, Italy. The session took place on Monday, 7 July, 2014.
The title of Dr. Hoering's session was Biomarkers in Oncology Clinical Trials. Speakers in the session included Michael LeBlanc, Ph.D. of the Fred Hutchinson Cancer Research Center; Shigeyuki Matsui of the Institute of Statistical Mathematics, Tokyo and Donna Ankerst, Ph.D.of the Technische Universitaet Muenchen, Germany. John Crowley, Ph.D. from CRAB served as the discussant. Session topics included the direction of subgroup modeling in Phase III clinical trial designs, maintenance of clinical risk calculators and statistical analysis plans in Phase III trials.
For more information about the 2014 IBC Conference please visit the event website at https://www.biometricsociety.org.
GiveBIG 2014: Thank You!
With your help, we raised over $6,600 in support of the impactful work we're doing at CRAB.
Your contributions will help us advance the standard of care and improve treatment for cancer patients. Thank you again for supporting our mission and standing with us in our belief that "Every Cancer Patient Counts".
Missed GiveBIG Day 2014? Not a problem! CRAB accepts donations year-round. Check out our donation page at Donate to CRAB for more information and a secure online donation link.
CRAB CSO Antje Hoering, PhD., gave an invited talk at one of the major methods workshops of the Annual Meeting of the American Association for Cancer Research (AACR) on April 5, 2014.
Nearly 18,000 researchers, patient advocates and other professionals in the field of cancer from around the world attended the AACR annual meeting. Dr. Hoering's talk was titled "Statistical Designs of Complex Phase II Trials and Definitive Phase III Studies in the Era of Targeted agents" and was part of the workshop: "Insights in the Era of Personalized Cancer Therapy and Targeted Therapies: Definitive Advanced Stage Clinical Trials." For more information about the event please visit the AACR website at aacr.org.
CRAB Collaborates with the International Biometric Society
CRAB's Chief Scientific Officer Antje Hoering, Ph.D., has been elected as a representative from the Western North American Region of the International Biometric Society: http://www.biometricsociety.org/. The IBS promotes the development and application of statistical and mathematical theory and methods in the biosciences, including biomedical science and public health, agriculture, ecology, environmental sciences, forestry, and allied disciplines. Dr. Hoering will represent the organization to the international governing body of the IBS.
CRAB to Present at Clinical Trials Conference
CRAB will give an oral presentation at the Annual Meeting of the Society For Clinical Trials (SCT) in May of 2014. The presentation is titled “Mixed Mode Follow-up for an Aging Study Population” and will focus on participants of the SELECT clinical trial. For more information on SCT visit their website. Information on SELECT may be found via the National Cancer Institute.
Give Big to CRAB & Grow your Gift! Donate today to make a BIG impact!
Today is the Seattle Foundation's GiveBIG event. GiveBIG is a unique, one-day, online charitable giving event that supports local charities, including CRAB. In addition to the donations CRAB receives, GiveBIG contributions will also be partially matched by a "stretch pool" provided by the Seattle Foundation and GiveBIG sponsors. The more donations CRAB receives, the more we will get from the stretch pool!
Your contributions will help us continue to advance the standard of care for cancer patients and help improve treatment for many cancer types.
Thank you for your contribution!
Participation is fast and easy! Here's how:
Thank you for supporting CRAB!
CRAB is poised to participate in the fourth annual online giving event on May 6th.
GiveBIG is the Seattle Foundation's one-day online charitable giving event to inspire people in the community to give generously to non-profit organizations, like CRAB, that make our region a stronger community for all.
From 12:00 a.m. to 12:00 a.m. on May 6th, every donation made to CRAB through the Seattle Foundation's website will receive a pro-rated portion of the matching funds (or "stretch") pool - thanks to the Seattle Foundation and the GiveBIG sponsors.
The amount of the "stretch" depends on the size of the stretch pool and how much is raised in total donations on GiveBIG day (we will "stretch" all donations up to $5,000 per donor, per organization.)
Participation is fast and easy!
Thank you for supporting CRAB!
Strength for CRAB Partnerships
CRAB is proud to have worked in partnership with SWOG and to have received a high score for SWOG's participation in the new National Clinical Trials Network (NCTN) program starting in March of 2014. The SWOG Statistical and Data Management Center (SDMC) is co-located at CRAB and Fred Hutchinson Cancer Research Center.
CRAB's John Crowley and Antje Hoering taught at UW Summer Institute in Biostatistics
Drs. John Crowley and Antje Hoering conducted a workshop on the Design of Clinical Trials in Oncology at the 2nd Summer Institute in Biostatistics (SIB 2013), August 12 to 16, in the South Campus Center of the University of Washington in Seattle.
This Institute was a series of two-and-a-half day workshops conducted by experts in the field and was designed to introduce participants to modern issues in the design and conduct of clinical trials and the statistical analysis of clinical trial data. Drs. Crowley and Hoering covered all phases of oncology clinical trials (Phase I-III).
Details about the event are available in this PDF:download
John Crowley Awarded the 2013 Breslow Lecture
John Crowley, PhD, President and CEO of CRAB, was awarded the distinguished 2013 Norman E. Breslow Lectureship from the University of Washington’s School of Public Health. Dr. Crowley will give a presentation for the School titled "A Brief History of Survival Analysis". The event will run from 3:30 to 5:00pm on Thursday, June 13th, 2013 in Room T-733 of the UW Health Sciences building.
The Norman E. Breslow Distinguished Lectureship was established in 2006 to honor the instrumental scientific contributions of Norman E. Breslow in the Department of Biostatistics of the School of Public Health and Community Medicine. The Lectureship is awarded annually to an individual who has made important contributions to the advancement of biostatistical methodology and its applications in the health sciences. Former Breslow Lecturers include Mitchell H. Gail of the National Cancer Institute and David Clayton of Cambridge University.
Details about the event are available in this PDF: download
For more information, contact Sandra Coke at the School of Public Health: 206-685-9496.
CRABCares at the Free to Breathe Run/Walk
On September 7th, 2013 CRAB employees participated in the Free to Breathe 5K Run/Walk & 1-Mile Walk event. The event featured 404 participants who raised over $55,000 to support lung cancer research.
The CRABCares mission is aligned with the goal of such events: to support community efforts in the fight to prevent and cure cancer.
CRAB Presenting at Cancer Prevention Conference
CRAB will give a poster presentation at the American Society of Preventative Oncology (ASPO) in March 2014. The presentation is titled “Retention of Minority Populations in the Selenium and Vitamin E Cancer Prevention Trial” and will focus on participants of the SELECT clinical trial. For more information on ASPO visit their website. Information on SELECT may be found via the National Cancer Institute.
Partnership in Cancer Trials Brings Hope for Patients
Cancer Research And Biostatistics (CRAB) recently announced enrollment of the first patient into the inaugural clinical trial sponsored by its Clinical Trials Consortium (CTC). The CRAB CTC mission is to ensure rapid clinical testing of new and innovative cancer treatments, and is focusing on lung cancer as its first target. By engaging front-line treating oncologists to push the boundaries of patient care, the aim is to improve the standard of care and extend overall survival. The trial is being funded by Onyx Pharmaceuticals, Inc., an Amgen subsidiary.
You Shop and Amazon Donates to CRAB
In November 2013, Amazon.com launched a charitable program called AmazonSmile. This program is designed to give 0.5% of the price of every eligible purchase made to the charity of your choice. CRAB is participating in the program and is listed on the Amazon Smile site as “Cancer Research And Biostatistics”. Almost every product sold by Amazon is eligible and there is no cap on the amount Amazon will donate. Thank you for considering this option when making your online purchasing decisions!
CRAB Collaborates with Local Giving Campaigns
CRAB recently participated in two local fundraising campaigns: the King County Chapter of the Combined Federal Campaign (CFC) and the King County Government’s Employee Giving Program Expo (KCEGP). CRAB was proud to participate in these events.
The CFC creates opportunities for federal civilian, postal, and military employees to donate to local, national, and international non-profit organizations. CRAB joined other participating organizations to publicly thank the military and federal employees for their participation in the Combined Federal Campaign’s employee giving program.
The KCEGP showcases King County’s Employee Giving Program, a philanthropy resource for County employees. The Program includes an Annual Giving Drive in which County employees may make donations to hundreds of local non-profit organizations.
For Immediate Release - Launch of Project Survival℠: Collaboration Aims to Uncover First Ever Biomarker for Pancreatic Cancer
Berg, BIDMC Cancer Center, CRAB/Pancreatic Cancer Research Team work together to eradicate disease
BOSTON, April 7, 2015 – The search to discover and validate the first-ever clinical biomarker to diagnose and treat pancreatic cancer is at the foundation of a new, cross-sector collaboration. Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological research approach; the Cancer Center at Beth Israel Deaconess Medical Center (BIDMC), a Harvard Medical School teaching hospital, and the Pancreatic Cancer Research Team (PCRT) managed by Cancer Research And Biostatistics (CRAB) announced today they will work together to eradicate the disease.
According to The National Cancer Institute, nearly 47,000 Americans were diagnosed with pancreatic cancer in 2014, a disease from which only 6.7 percent will survive five years. "Pancreatic cancer will become the No. 2 cause of cancer death in the United States within five years, surpassing both breast and colon cancer," said James Moser, MD, director of the research team for BIDMC's new Pancreas and Liver Institute and an Associate Professor of Surgery at Harvard Medical School.
"Finding a new biomarker will bring real hope to patients with pancreatic cancer. Currently, 70 percent of people with even the smallest pancreatic tumors pass up potentially life-saving treatments. We believe that our new collaboration with Berg and the Pancreatic Cancer Research Team represents the dawn of the kind of precision medicine needed to beat this terrible disease."
You may access the full press release via this PDF.
Seattle, WA. November 3rd, 2014. Cancer Research And Biostatistics (CRAB) announced today that its Board of Directors named Dr. Antje Hoering as the organization’s next Chief Executive Officer, effective January 1, 2015. Dr. Hoering brings distinguished academic and scientific achievements, executive leadership and over 15 years of experience to the role. Dr. Hoering, currently the Chief Scientific Officer at CRAB, presently serves as the lead statistician for the SWOG Myeloma Committee and is an active member of the Myeloma Steering Committee for the National Clinical Trials Network. Dr. Hoering also serves as the Director of the Biostatistics Core for a SPORE grant funded through the Sarcoma Alliance for Research Through Collaboration, and is the Co-Director of the Biostatistics Core for a Program Project through the Myeloma Institute for Research and Therapy.
Dr. John Crowley, CRAB’s current CEO says “Antje brings a unique and comprehensive background in applied and methodological research in biostatistics, encompassing areas such as the design and analysis of oncology clinical trials, as well as the analysis of a wide variety of correlative data. I have worked with Antje for 10 years at CRAB, and am proud to hand over the leadership reins to her.”
Dr. Antje Hoering comments, “I am honored and humbled to be taking over the reins from our founder, John Crowley. This is a very exciting time for oncology clinical trials and CRAB. There have been great advances in the treatment of cancer over the last few years and it is now more important than ever to definitively test the efficacy and tolerability of these treatments in soundly-designed clinical trials. CRAB offers an integrated, state-of-the-art infrastructure including sophisticated statistics, secure electronic data capture as well as experienced data management to lead such trials.”
Hoering will succeed John Crowley, CRAB’s founder and CEO since 1997, who will stay on to focus on research and project activities and will continue to serve as CRAB’s Chairman of the Board.
Dr. Hoering will be based at CRAB’s headquarters in Seattle, WA.
About Cancer Research And Biostatistics (CRAB)
CRAB is a non-profit organization whose mission is to help conquer cancer and other diseases through the application of biostatistical principles and innovative data management methods. CRAB provides a complete suite of cancer clinical trial services including the design of therapeutic and prevention trials, customized electronic data capture platforms, and data management and statistical services from clinical protocol design to final data analysis and presentation.
For more information, visit www.crab.org.
Media Contact for CRAB
Vice President, Chief Business Development Officer
Responsibility for Pancreatic Cancer Research Team Moves to Seattle Non-Profit Institution
Seattle, WA. September 10, 2014 Seattle’s own Cancer Research And Biostatistics (CRAB), and Translational Drug Development (TD2) in Scottsdale, would like to jointly announce CRAB’s assumption of responsibility for the PCRT, a world-renowned consortium comprised of a team of pancreatic cancer experts committed to improve treatment outcomes for patients with this deadly cancer.
Founded by leaders in pancreatic cancer clinical research, the PCRT is a consortium of more than 40 clinics and leading research institutions worldwide and serves as a premiere resource for the latest clinical trials. In addition, the PCRT provides a valuable collaborator for biotech and pharmaceutical companies looking to develop new agents for patients with pancreas cancer. This network provides the world's most coordinated effort dedicated to rapidly translating research discoveries into new treatments and care.
“Dr. John Crowley and CRAB have a distinguished record in clinical trials excellence. The PCRT has been working with the CRAB team for over ten years. It is gratifying to see CRAB take this growing group of devoted investigators to the next level”, said Daniel D. Von Hoff, M.D., FACP, Physician in Chief, Distinguished Professor, Translational Genomics Research Institute (TGen), Chief Scientific Officer, Scottsdale Healthcare, and one of the Founders and current Board member of PCRT.
You may access the full press release at this link: http://www.prweb.com/releases/2014/9/prweb12163611.htm
Appointment of CFO Represents Transition
Former long-term Battelle financial manager fills Chief Financial Officer role at leading cancer research organization
Seattle, WA, March 28, 2014 – Cancer Research And Biostatistics (CRAB) today announced the appointment of William S. Charters to the position of Chief Financial Officer. Mr. Charters will guide the fiscal direction of CRAB while it seeks to expand current and future collaborations with cancer centers, clinical research consortia, private industry, and non-profit groups involved in oncology clinical trials.
CRAB’s mission is to help conquer cancer and other diseases through the application of its expertise in biostatistical principles and innovative data management methods. Prior to joining CRAB, Mr. Charters served as financial manager implementing financial and operational initiatives in support of strategic objectives for Battelle Memorial Institute focused on improving public health and data analytics, working with government and commercial clients to accelerate innovation in health and life sciences. Mr. Charters holds an MBA from the Gonzaga University School of Business.
Mr. Charters will report to John Crowley, PhD, Chief Executive Officer, a leader in the development and application of biostatistical methods to improve oncology clinical research. “Appointing Bill to the CFO role is a reflection of our desire to position CRAB into the future,” Dr. Crowley provided in a statement. “He will provide his leadership across the organization, and further develop the impact CRAB can have on helping to conquer cancer.”
Office: 206 839 1734
News & Events > Archive
2013 Marvin Zelen Leadership Award in Statistical Science Recipient: John Crowley, Ph.D.
John Crowley, PhD, President and CEO of CRAB has been chosen to receive the 2013 Marvin Zelen Leadership Award in Statistical Science. Dr. Zelen is world-renowned for development of clinical cancer trial methodologies, among other foundational advancements in biostatistics.
The award, granted by the Harvard School of Public Health in the name and spirit of Dr. Zelen, recognizes an individual in government, industry or academia who by virtue of his or her outstanding leadership has greatly impacted the theory and practice of statistical science. The most distinguishing criterion is the awardee’s contribution to the creation of an environment in which statistical science and its applications have flourished. Dr. Crowley will deliver a public lecture on statistical science at the Harvard School of Public Health on Friday, May 24 where he will be presented with a citation and an honorarium.
John is well-known for his visionary leadership in three areas in which Marvin himself set the standard: i) development of an outstanding statistical center within the National Cancer Institute (NCI) cooperative group program, ii) founding of a non-profit corporation whose mission is to “help conquer cancer … through the application of biostatistical principles …”, and iii) promotion of statistical science internationally by exporting modern clinical trials methodology to researchers in Asia and Latin America. John is also recognized for his outstanding individual contributions to methodological research in survival analysis, to substantive research on the treatment and prevention of cancer, and to the training, mentoring and inspiring of the next generation of statistical scientists. He has over 350 peer-reviewed publications and has contributed to and edited several books on survival analysis and methodology of clinical trials. Dr. Crowley received his undergraduate degree from Pomona College, Claremont, CA, and his Master of Science and PhD in Biomathematics from the University of Washington, Seattle. He is a fellow of the American Statistical Association and the American Association for the Advancement of Science. Crowley led the Biostatistics Unit at the University of Wisconsin Clinical Cancer Center, was the head of Biostatistics Program at the Fred Hutchinson Cancer Research Center, and recently completed nearly 30 years as the Group Statistician of SWOG, a national clinical trials consortium funded by the NCI. In 1997 Dr. Crowley founded and currently serves as the CEO and President of Cancer Research And Biostatistics.
Expert in oncology statistics fills Chief Scientific Officer role at leading cancer research organization
Seattle, WA, January 10, 2013 – Cancer Research And Biostatistics (CRAB) today announced the appointment of Antje Hoering, PhD to the newly-created position of Chief Scientific Officer. Dr. Hoering will guide the scientific direction of CRAB while it seeks to expand current and future collaborations with cancer centers, clinical research consortia, private industry, and non-profit groups involved in oncology clinical trials.
CRAB’s mission is to help conquer cancer and other diseases through the application of its expertise in biostatistical principles and innovative data management methods. Dr. Hoering has led the CRAB statistical team for eight years, making significant contributions as the lead statistician of the SWOG Myeloma Committee, the SWOG Early Therapeutics Committee, and the Stand Up To Cancer Pancreatic Cancer Dream Team. Her accomplishments in the field of oncology research have contributed to significant advancements in the field, reflected in her co-editing the third edition of the Handbook of Statistics in Clinical Oncology. She has affiliate appointments at the Fred Hutchinson Cancer Research Center and at the University of Washington, Seattle.
Prior to joining CRAB, Dr. Hoering worked as a Senior Research Associate and Assistant Professor in Biostatistics at the Mayo Clinic and was a research scientist at Insightful Corporation. Dr. Hoering holds a PhD in Physics from the Max Planck Institute for Nuclear Physics.
Dr. Hoering will report to John Crowley, PhD, Chief Executive Officer, a leader in the development and application of biostatistical methods to improve oncology clinical research. “Appointing Antje to the CSO role is a reflection of the immense respect I have for her expertise and commitment to improve oncology patient outcomes,” Dr. Crowley provided in a statement. “In this expanded role, she will provide her leadership across the organization, and further develop the impact CRAB can have on helping to conquer cancer.”
About Cancer Research And Biostatistics (CRAB):
CRAB is a non-profit organization that provides a complete suite of cancer clinical trial services including the design of therapeutic and large scale prevention trials, customized electronic data capture platforms, and data management and statistical services from clinical protocol design to final data analysis and presentation.
Office: 206 839 1734