CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cytel Inc., a provider of clinical research services and software to the biopharmaceutical industry and pioneer in adaptive trial design, today announced the publication of an important article in the influential New England Journal of Medicine. The review article, ‘Adaptive Designs for Clinical Trials,’ is co-authored by Cyrus Mehta, Ph.D., President of Cytel and Adjunct Professor of Biostatistics, Harvard School of Public Health, and Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart and Vascular Center, and Professor of Medicine, Harvard Medical School.
“We hope this paper helps medical researchers throughout the world design trials that maximize the likelihood of finding effective therapies for patients, while minimizing the risks.”
Adaptive designs have been proposed as a way to address limitations of randomized controlled trials, having the potential to increase efficiency, deliver benefits to trial participants and future patients, and improve the likelihood of finding a true benefit of a therapy, if one exists. However, the statistical methods used tend to be more complex and, as such, dissemination of knowledge around their application is essential. The focus of the New England Journal of Medicine publication is to promote understanding of adaptive designs particularly in a confirmatory setting. The authors use case studies to highlight statistical and operational considerations as well as benefits and limitations of 4 important adaptation types:
• Seamless Phase 2–3 Design
• Sample-Size Re-estimation
• Changing the Primary End Point
• Biomarker-Driven Adaptive Population Enrichment Designs
Dr. Mehta, an expert on adaptive clinical trial design and implementation commented, “There has been considerable misunderstanding and confusion among both clinicians and statisticians about the role of adaptive designs in clinical trials. This article attempts to explain through actual case studies, without technical jargon, the different types of adaptive designs for confirmatory clinical trials, and the opportunities that they create for more efficient allocation of patient resources. An interactive graphic demonstrates how statistical validity is maintained despite data-dependent increases in the sample size of an ongoing study.” Dr. Bhatt added, “We hope this paper helps medical researchers throughout the world design trials that maximize the likelihood of finding effective therapies for patients, while minimizing the risks.”
The article is available to subscribers to the New England Journal of Medicine at http://www.nejm.org/doi/full/10.1056/NEJMra1510061 or upon request to mehta@cytel.com.
About Cyrus Mehta
Dr. Mehta is co-founder and President of Cytel and a respected biostatistics thought leader. He has published more than 100 research articles in scientific journals including JASA, Biometrics, Biometrika, Statistics in Medicine, and Circulation, as well as the New England Journal of Medicine and regularly provides guidance and training to biopharmaceutical companies, academic collaborators, and FDA statisticians. Mehta is a Fellow of the American Statistical Association and Adjunct Professor of Biostatistics at the Harvard T.F. Chan School of Public Health.
About Cytel
Cytel is shaping the future of drug development. Its cutting-edge software and biometrics outsourcing services enable pharmaceutical and biotechnology companies of all sizes to improve clinical success rates. Cytel has designed and implemented more adaptive trials than any other clinical research organization and has a track record of success submitting adaptive designs to the FDA and other regulatory agencies.
Publication Details
Bhatt, D.L. and Mehta, C. (2016) ‘Adaptive designs for clinical trials’, New England Journal of Medicine, 375(1), pp. 65–74. doi: 10.1056/nejmra1510061.
http://www.nejm.org/doi/full/10.1056/NEJMra1510061
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Liz Cole, +1 617-661-2011
Content Marketing Manager
Liz.cole@cytel.com
