Public Engagement and Clinical Trials

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 find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along 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.Table of ContentsFront Matter1 Introduction2 Framing the Problem3 Recruitment Challenges in Clinical Trials for Different Diseasesand Conditions4 Models for Public Engagement5 Messages and Methods for Public Engagement6 The Media7 Novel Clinical Trial Designs8 The Health System's Structure and Culture9 Toward a Patient-Centered Strategy for Clinical TrialsReferencesAppendix A: Workshop AgendaAppendix B: The Clinical Trials ProcessAppendix C: Participant Biographies