Envisioning a Transformed Clinical Trials Enterprise for 2030

The National Academies’ Forum on Drug Discovery, Development, and Translation will host a virtual public workshop on Jan 26, 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 provide an overview discussion on how an envisioned 2030 clinical trials enterprise may differ from the current system. It will discuss key challenges and opportunities in improving person-centeredness and inclusivity, building resilience and transparency, and integrating new technologies.

The workshop session will consider changes in the clinical trials enterprise made in response to COVID-19 that may establish positive and sustainable examples for the future, and consider specific action steps that individual stakeholders could take to support an envisioned change from 2020 to 2030.

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

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. These opportunities hold great promise for advancing our understanding of health maintenance and prevention, disease progression, and developing new therapies for patients. At the same time, the clinical research enterprise is strained by rising costs, an evolving regulatory and economic landscape, increasing clinical trial complexity, difficulties in the recruitment and retention of research participants, and a clinical research workforce that is under tremendous stress. Some, but not all, of these challenges and opportunities were predicted in the 2011 National Academies workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020. There is now a need for stakeholders from across the clinical research lifecycle to consider lessons learned from progress and setbacks over the past 10 years and broadly consider 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.