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International Clinical Trials

Adapting to Adaptive Studies

Adaptive studies promise significantly lower costs and shorter timelines. Michael J Rosenberg of Health Decisions reviews the organisational foundations for conducting adaptive studies most productively and explains why web-based EDC systems are not up to the task

Adaptive clinical research promises profound and dramatic benefits to the pharmaceutical industry. Adaptive programmes, which allow changes during a trial based on analysis of data collected up to the time of the change, provide major advances such as shortening development time, reducing the incidence of treating patients with ineffective or unsafe doses, and allowing regulatory agencies a more nuanced assessment of both efficacy and safety.

Several trends have converged to enable adaptive methods, including increased computational power, more efficient communications technology, and powerful supporting statistical methodologies. Agencies such as the US Food and Drug Administration and the EMEA have acknowledged the significance of adaptive methods in a variety of ways. Moreover, the direct experience of research groups that deal regularly with relevant design and reporting issues, including my own, confirms not only a growing receptiveness of regulators to adaptive methods, but also encouragement of well designed adaptive studies.

This article summarises the organisational and process issues in adaptive research. After briefly discussing the principles of adaptive research and the types of optimisations an adaptive trial can enable, the focus for the balance of the article will shift to what is required to make the powerful engine of adaptive research deliver maximum benefits.

WHAT IS ADAPTIVE RESEARCH?

The term ‘adaptive research’ broadly denotes changes that can occur during the course of a study or development programme without compromising validity or integrity. An adaptive trial design can correct mistaken assumptions or seize an opportunity to optimise the trial. Often the result is shorter timelines, lower costs and superior information for sponsors, regulators and future prescribing physicians.


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Dr Michael Rosenberg, MPH is the founder and CEO of Health Decisions. He was awarded Ernst & Young’s Entrepreneur of the Year in Health Sciences in 2002, and has led Health Decisions to recognised success. The author of more than 150 scientific articles, Michael serves on advisory groups in business, technology and medicine. He is Clinical Professor of Obstetrics and Gynaecology for the School of Medicine and Adjunct Professor of Epidemiology for the School of Public Health at the University of North Carolina. He practiced emergency medicine for more than 20 years. 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 and his master’s degree in Epidemiology and Biostatistics from Harvard University.
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Dr Michael Rosenberg
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