Envisioning a Transformed Clinical Trials Enterprise for 2030 – Session 4

The National Academies’ Forum on Drug Discovery, Development, and Translation will host a virtual public workshop on May 11, 2021 as part of a web series forum of events to discuss critical policy for advancement of biopharmaceutical innovation nationally and globally.

This virtual public workshop will provide a venue for stakeholders to consider a transformed clinical trial enterprise for 2030. Workshop participants will consider lessons learned from progress and setbacks over the past 10 years, since the previous workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States, and, looking forward, discuss goals and key priorities for advancing a clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health delivery system of 2030.

The event will consider ways the thoughtful and deliberate use of new technologies could improve the clinical trials enterprise and support goals outline in prior webinar sessions.

Background

Clinical trials research has changed dramatically over the last decade. The biological, physical, and digital spheres are merging; clinical research and health care are at a critical juncture; new approaches enable the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are changing possibilities for the conduct of clinical research.

A planning committee of the National Academies of Sciences, Engineering, and Medicine will plan and conduct a virtual public workshop designed to consider a transformed clinical trial enterprise for 2030. Key priority challenges and opportunities framing the 2030 agenda are:

• Diversity and inclusion of clinical trial participants
• Convergence of clinical research and clinical practice
• Clinical trial data sharing
• Incorporation of new technologies into drug research and development
• Workforce and career development
• Public engagement and partnership
• Regulatory Environment
• Cultural and Financial Incentives
• Practical short- and long-term goals for improving the efficiency, effectiveness, person-centeredness, inclusivity, and integration with healthcare of the clinical trials enterprise.

Planning Committee

• Steven Galson (Co-Chair), Amgen
• Ester Krofah (Co-Chair), FasterCures, Milken Institute
• Amy Abernethy, Office of the Comissioner, FDA
• Anita LaFrance Allen, University of Pennsylvania
• Christopher P. Austin, National Center for Advancing Translational Sciences, NIH
• Howard A. Burris, Sarah Cannon
• Luther T. Clark, Merck & Co., Inc.
• Giselle Corbie-Smith, The University of North Carolina at Chapel Hill
• M. Khair ElZarrad, Center for Drug Evaluation and Research, FDA
• Jennifer Goldsack, Digital Medicine Society
• Richard A. Moscicki, PhRMA
• Amy Patterson, National Heart, Lung, and Blood Institute, NIH
• Joseph Scheeren, Critical Path Institute
• Anantha Shekhar, University of Pittsburgh
• Pamela Tenaerts, Clinical Trials Transformation Initiative
• Christopher Yoo, Systems Oncology

For additional information on the workshop series, please visit the project page.