Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to determine whether they are effective and to assess any harm that may arise from treatment. There is growing recognition, however, that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. Many clinical trials never meet their recruitment goals and others accrue patients far too slowly. The divide between clinical research and clinical care is growing wider, with many patients and their physicians far removed from the clinical trials that are needed to create the data necessary to bring scientific discoveries into clinical practice.

To further examine the current challenges to U.S. clinical trials, the IOM Forum on Drug Discovery, Development, and Translation, in collaboration with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011 to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials. The workshop covered topics such as recruiting and retaining trial participants, increasing practicing clinicians’ participation in and referrals to trials, and strengthening public understanding of clinical trials. This document is a summary of the workshop.

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