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.
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.