Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health.

Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs.

Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research—from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON STRATEGIES FOR RESPONSIBLE SHARING OF CLINICAL TRIAL DATA
• Reviewers
• Preface
• Abstract
• Summary
  • GUIDING PRINCIPLES FOR SHARING CLINICAL TRIAL DATA
  • KEY STAKEHOLDERS INVOLVED IN DATA SHARING
  • WHAT DATA SHOULD BE SHARED AND WHEN IN THE LIFE CYCLE OF A CLINICAL TRIAL
  • ACCESS TO CLINICAL TRIAL DATA
  • THE FUTURE OF CLINICAL TRIAL DATA SHARING IN A CHANGING LANDSCAPE
• 1. Introduction
  • STUDY CONTEXT
  • CHARGE TO THE COMMITTEE AND STUDY SCOPE
  • STUDY APPROACH
  • ORGANIZATION OF THE REPORT
  • REFERENCES
• 2. Guiding Principles for Sharing Clinical Trial Data
  • OVERVIEW OF KEY POTENTIAL BENEFITS AND RISKS
  • GUIDING PRINCIPLES
  • THE COMMITTEE'S APPROACH TO APPLYING THE PRINCIPLES
  • REFERENCES
• 3. The Roles and Responsibilities of Stakeholders in the Sharing of Clinical Trial Data
  • PARTICIPANTS
  • FUNDERS AND SPONSORS
  • REGULATORY AGENCIES
  • INVESTIGATORS
  • RESEARCH INSTITUTIONS AND UNIVERSITIES
  • JOURNALS
  • PROFESSIONAL SOCIETIES
  • RECOMMENDATION
  • REFERENCES
• 4. The Clinical Trial Life Cycle and When to Share Data
  • THE CLINICAL TRIAL LIFE CYCLE
  • WHAT DATA SHOULD BE SHARED
  • WHEN DATA PACKAGES SHOULD BE SHARED
  • RECOMMENDATION
  • REFERENCES
• 5. Access to Clinical Trial Data: Governance
  • OPEN ACCESS
  • APPROACHES TO MITIGATING THE RISKS OF DATA SHARING
  • CREATING A LEARNING SYSTEM
  • RECOMMENDATION
  • REFERENCES
• 6. The Future of Data Sharing in a Changing Landscape
  • LOOKING FORWARD
  • INFRASTRUCTURE CHALLENGES
  • TECHNICAL CHALLENGES
  • WORKFORCE CHALLENGES
  • SUSTAINABILITY CHALLENGES
  • STRUCTURE FOR COLLABORATIVE NExT STEPS
  • RECOMMENDATION
  • REFERENCES
• Appendixes
  • Appendix A Study Approach
  • Appendix B Concepts and Methods for De-identifying Clinical Trial Data
  • Appendix C Legal Discussion of Risks to Industry Sponsors
  • Appendix D Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization
  • Appendix E Biosketches of Committee Members

This study was supported by contracts between the National Academy of Sciences and the U.S. National Institutes of Health (HHSN263201200074I), U.S. Food and Drug Administration, AbbVie Inc., Amgen Inc., AstraZeneca Pharmaceuticals, Bayer, Biogen Idec, Bristol-Myers Squibb, Burroughs Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Johnson & Johnson, Medical Research Council (UK), Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Takeda, and The Wellcome Trust. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.

Suggested citation:

Institute of Medicine (IOM). 2015. Sharing clinical trial data: Maximizing benefits, minimizing risk. Washington, DC: The National Academies Press.

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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.