Overview

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 Contents Front Matter 1 Introduction 2 Framing the Problem 3 Recruitment Challenges in Clinical Trials for Different Diseases and Conditions 4 Models for Public Engagement 5 Messages and Methods for Public Engagement 6 The Media 7 Novel Clinical Trial Designs 8 The Health System's Structure and Culture 9 Toward a Patient-Centered Strategy for Clinical Trials References Appendix A: Workshop Agenda Appendix B: The Clinical Trials Process Appendix C: Participant Biographies

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