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European Biopharmaceutical Review

Operational Adaptive Research

Adaptive clinical research, defined as research that allows changes in a trial or programme while it is underway, is increasingly used in pharma as a means of shortening development timelines and reducing costs – in short, improving efficiency. While there is much industry discussion of adaptive methods, the range of topics is restricted by an unduly narrow definition that limits the concept to midcourse changes in study design. Allowing such design changes is an important and valuable aspect of adaptive methods that encompasses techniques such as sample size re-estimation, pruning of treatment arms, alteration of randomisation ratios, Bayesian analyses, and similar methodologies.

There can be little question about the benefit of such design-level changes based on their ability to incorporate knowledge as it is generated and to change how an evaluation proceeds. Two of the simplest techniques – sample size re-estimation and pruning of treatment arms during dose-finding – are so valuable that I believe they should be routinely considered in study planning – a sentiment echoed by the PhRMA working group on adaptive methodology (1). Failure to at least consider employing these techniques risks wasting time and money – and often substantial amounts of both.


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Michael Rosenberg, MD, MPH, is President and Chief Executive Officer of Health Decisions, Inc, a private clinical research company. Michael has been involved with the strategic design and execution of pharmaceutical development programmes for more than 25 years. He currently focuses on the strategic aspects of development, utilising new technology and processes to improve the quality and timeliness of decisionmaking on multiple levels to reduce development time. The author of more than 150 scientific articles, Michael serves on numerous advisory groups in business, technology and medicine. He currently serves as Clinical Professor of Obstetrics and Gynecology at the School of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina. He also remains active in the practice of emergency medicine. His professional achievements have been recognised by fellowship in the American College of Physicians, American College of Preventive Medicine, and the American College of Epidemiology. Michael received his undergraduate and medical degrees from the University of California, US and a Master’s degree in Epidemiology and Biostatistics from Harvard, US. He was also selected at Ernst and Young’s Entrepreneur of the Year in the Life Sciences Division in 2000.
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Michael Rosenberg
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