Envisioning a Transformed Clinical Trials Enterprise for 2030

The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021. Table of Contents Front Matter 1 Introduction 2 Defining the Vision 3 Enhancing Outcomes in a More Person-Centered and Inclusive Clinical Trials Enterprise 4 Practical Applications for Technology to Enhance the Clinical Trials Enterprise 5 Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise 6 Opportunities for Transformation References Appendix A: Health Affairs Blog Posts Appendix B: Speaker and Moderator Biographies Appendix C: Workshop Agendas