Excerpt

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.

Contents

• THE NATIONAL ACADEMIES
• PLANNING COMMITTEE FOR THE WORKSHOP SERIES ON IMPROVING THE CLINICAL TRIAL PROCESS IN THE UNITED STATES
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• Acronyms
• 1. Introduction
• 2. Framing the Problem
  • THE CURRENT LANDSCAPE OF CLINICAL TRIALS
  • PANEL PRESENTATIONS AND DISCUSSION
• 3. Recruitment Challenges in Clinical Trials for Different Diseases and Conditions
  • CARDIOVASCULAR SURGERY
  • WORKING WITH UNDERSERVED COMMUNITIES
  • MENTAL HEALTH
• 4. Models for Public Engagement
  • LOVE/AVON ARMY OF WOMEN
  • 23ANDME
  • RESEARCHMATCH
• 5. Messages and Methods for Public Engagement
  • MESSAGES
  • MESSENGERS
• 6. The Media
  • BALANCED COVERAGE
  • RELATIONSHIPS WITH RESEARCHERS
  • RELATIONSHIPS WITH THE AUDIENCE
  • CONFLICT OF INTEREST
• 7. Novel Clinical Trial Designs
  • ADAPTIVE CLINICAL TRIAL DESIGNS
  • USING POINT-OF-CARE CLINICAL TRIALS TO CREATE A LEARNING HEALTH CARE SYSTEM
  • THE FOOD AND DRUG ADMINISTRATION PERSPECTIVE
• 8. The Health System’s Structure and Culture
  • BUILDING A SUPPORTIVE CLINICAL TRIALS ENVIRONMENT IN ACADEMIA
  • PUBLIC-PRIVATE PARTNERSHIPS IN CANCER TRIALS
  • ENGAGING COMMUNITY PHYSICIANS IN RHEUMATOID ARTHRITIS RESEARCH
• 9. Toward a Patient-Centered Strategy for Clinical Trials
  • THE CHANGING POLITICS OF CLINICAL TRIAL ENGAGEMENT
  • CLOSING PANEL
• References
• APPENDIXES
  • Appendix A Workshop Agenda
  • Appendix B The Clinical Trials Process
  • Appendix C Participant Biographies

Rapporteurs: Victoria Weisfeld, Rebecca A. English, and Anne B. Claiborne

This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO No. 158 and HHSF223001003T), American Society for Microbiology; Amgen Inc.; Association of American Medical Colleges; Bristol-Myers Squibb; Burroughs Wellcome Fund; Celtic Therapeutics, LLLP; Critical Path Institute; Doris Duke Charitable Foundation; Eli Lilly and Co.; FasterCures; Foundation for the NIH; Friends of Cancer Research; GlaxoSmithKline; Johnson & Johnson; Merck and Co., Inc.; Novartis Pharmaceuticals Corporation; and Pfizer Inc.

Suggested citation:

IOM (Institute of Medicine). 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.