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Ancillary Data Management
For several studies coordinated by the Southwest Oncology Group, CRAB provides
pharmaceutical companies with detailed patient data beyond what the study's investigators
normally use in their endpoint analyses. This data will allow industry personnel to
conduct supplementary analyses of how a study drug is used in clinical practice.
Community Clinical Oncology Program The Community Clinical Oncology Program
(CCOP) makes clinical trials available in a large number of local communities in the
United States by linking community physicians with researchers in cancer centers. Local
hospitals throughout the country affiliate with a cancer center or a cooperative group.
This enables doctors to offer people participation in clinical trials more easily, without
having to travel long distances or leave their usual caregivers. Several of these programs
focus on encouraging minority populations to participate in trials.
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Cost of Treatment - An Economic Anaylsis of SWOG 9509: Cisplatin/Navelbine vs.
Carboplatin/Taxol for Advanced Non-Small Cell Lung Cancer
The objective of this project was to compare the cost of two different chemotherapy
regimes used to treat advanced non-small cell lung cancer, as administered to patients
enrolled in the Southwest Oncology Study S9509. CRAB provided ancillary analysis of all
cancer-related health care costs for these patients for up to two years of treatment. An
abstract summarizing the results of this study has been submitted to the American Society
of Clinical Oncology for publication.
Expanded Participation Project
The Expanded Participation Project (EPP) is a
demonstration project by the Cancer Therapy Evaluation
Program (CTEP) of the National Cancer Institute
(NCI) to provide selected physicians not affilliated with any Cooperative Group with
access to selected Cooperative Group clinical trials. CRAB manages the clinical data for
EPP participants enrolled in several studies coordinated by the Southwest Oncology Group.
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iKnowMed
iKnowMed is a cancer patient management software
package which includes clinical trial screening, qualification and charting
tools. The goals of this project are to increase the rate of recruitment and enrollment
into clinical trials, to encourage the electronic submission of clinical trial data by
clinicians and to further the standardization of clinical trial informatics as requested
by the National Cancer Institute. CRAB will coordinate the participation of up to six
Southwest Oncology Group pilot institutions in the iKnowMed project.
Informatics
CRAB is spearheading a number of programs to help streamline the data management process
for clinical trials.
- The NCI, FDA, pharmaceutical industry and clinical investigators have begun a joint
initiative to develop common definitions of endpoints in clinical trial designs for
breast, colon, lung, prostate and gynecological studies, a project known as RECIST (Response Evaluation Criteria in Solid Tumors). CRAB is
assisting with the inclusion of these common data elements in SWOG trials.
- CRAB is helping to scan existing SWOG paper patient files into an image database for
easier, online access.
- CRAB has developed a Web-based registration program allowing Clinical Research
Associates to register patients to clinical trials online, rather than by phone or regular
mail.
- CRAB is continuing to work on other Web-based applications to simplify the jobs of
physicians, nurses and data managers.
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Statistical Center - Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR
In the summer of 2001, CRAB took on the role of statistical center for the Myeloma Institute for Research and Therapy located at the University of Arkansas for Medical Sciences in Little Rock, Arkansas (http://myeloma.uams.edu/). The Myeloma Institute treats more multiple myeloma patients than any other cancer center in the world (approximately 500 new patients per year) and has pioneered many new advances in the diagnosis and treatment of this and related diseases. Prior to assuming the role of statistical center, CRAB had been involved in numerous consulting and contract projects with the Myeloma Institute. CRAB biostatisticians John Crowley and Joth Jacobson bring to the table over a decade of experience in the statistical analysis of myeloma data from their work on the Southwest Oncology Group Myeloma Committee. Along with new recruits Jason McCoy and Johanna Hardin, the team of myeloma statisticians at CRAB is busily working with researchers at the Myeloma Institute investigating new treatments, understanding the biology of multiple myeloma (including cytogenetics and gene array techniques), with the hope of one day finding a cure for this most complex disease.
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Western North American Region of the International Biometric Society
The Western North American Region (WNAR) is a professional organization open to biologists, statisticians and mathematicians living in the western portion of the United States and Canada who have a substantial interest in quantitative biology. WNAR's aim is to promote the understanding of quantitative biology and the application of statistical methods to biology. CRAB currently maintains the WNAR Web site and coordinates membership activities, including the membership database and group-wide mailings.
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