Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop


Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.

Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. This workshop examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. Workshop participants were asked to take a general, high-level approach in their examination of these issues, to take a pulse of the successes that have been realized and the challenges that have been encountered, and to consider how these experiences might inform the advancement of precision medicine. This proceedings is a summary of the workshop.