Envisioning a Transformed Clinical Trials Enterprise for 2030 – Session 2

The National Academies’ Forum on Drug Discovery, Development, and Translation will host a virtual public workshop on Feb 9, 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 achievable goals to enhance person-centeredness and inclusivity in the clinical trials enterprise; and discuss ways to improve public engagement and partnership.

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, featuring invited presentations and discussions on:

• Lessons learned from progress and setbacks over the past 10 years.

• How an envisioned 2030 clinical trials enterprise might differ from the current system.

• Key priority challenges and opportunities when it comes to the 2030 clinical trials enterprise.

• The following core themes in framing a 2030 agenda:

• 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.

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