Public Engagement and Clinical Trials: New Models and Disruptive Technologies

Rapid advances in biomedical research have drawn attention to the critical need for an effective clinical trial system that can generate the evidence needed to translate discoveries into improved patient care, and illuminate targets for further innovation. There is growing recognition, however, that the U.S. clinical trial enterprise is unable to keep pace with the national demand for actionable research results, and inefficiencies in the clinical trial enterprise limit our ability to realize the clinical benefits of scientific discovery. Many clinical trials never meet their recruitment goals and others are accruing patients far too slowly. In addition, the divide between clinical research and clinical practice is growing wider—physicians working in real world clinical care settings are removed from the clinical trials on which medical evidence and care choices are ideally made. Successfully engaging the broader public (including patients and communities) and medical professionals (community physicians and those practicing in academic medical centers) in the clinical trial enterprise is a significant challenge.

In light of these current challenges to clinical trials in the United States, this collaboration between the IOM (Institute of Medicine) Forum on Drug Discovery, Development, and Translation and Mount Sinai School of Medicine seeks to engage stakeholders and experts in an open discussion of current challenges and potential solutions to improving the capacity for efficient conduct of clinical trials in the United States through enhancing public engagement.