Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing - if carried out appropriately - could lead to improved clinical care and greater public trust in clinical research and health care. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities.
1 Front Matter; 2 Discussion Framework for Clinical Trial Data Sharing; 3 References; 4 Appendix A: Statement of Task; 5 Appendix B: Committee Biographies; 6 Appendix C: Figure 1: Data Flow from Participant to Analyzed Data and Reporting
National Research Council, Division of Behavioral and Social Sciences and Education, Institute of Medicine, and Families Board on Children, Youth, Steve Olson
Institute of Medicine, Board on the Health of Select Populations, and Transgender Health Issues and Research Gaps and Opportunities Committee on Lesbian, Gay, Bisexual
Institute of Medicine, Board on Population Health and Public Health Practice, Division of Health Promotion and Disease Prevention, Division of International Health
Institute of Medicine, Committee to Develop Methods Useful to the Department of Veteran Affairs in Estimating Its Physician Requirements, Joseph Lipscomb
Institute of Medicine, Board on Health Care Services, Committee on Cancer Clinical Trials and the NCI Cooperative Group Program, John Mendelsohn, Harold L. Moses, Sharyl J. Nass
Institute of Medicine, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Robert Giffin, Sally Robinson, Theresa Wizemann
Institute of Medicine, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Anne B. Claiborne, Rebecca A. English, Neil Weisfeld
Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Roundtable on Translating Genomic-Based Research for Health, National Cancer Policy Forum, Forum on Neuroscience and Nervous System Disorders, and Translation Forum on Drug Discovery, Development, Steve Olson, Autumn Downey
and Medicine National Academies of Sciences, Engineering, Health and Medicine Division, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Carolyn Shore, Amanda Wagner Gee, Theresa Wizemann
Board on Health Care Services, National Cancer Policy Forum, Institute of Medicine, An American Society of Clinical Oncology and Institute of Medicine Workshop, Margie Patlak, Sharyl J. Nass
Institute of Medicine, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Roundtable on Value and Science-Driven Health Care, Rebecca A. English, Julia Sanders, Claudia Grossmann
and Medicine National Academies of Sciences, Engineering, Health and Medicine Division, Board on Health Sciences Policy, Roundtable on Genomics and Precision Health, Sarah Beachy, Theresa Wizemann, Meredith Hackmann, Siobhan Addie
and Medicine National Academies of Sciences, Engineering, Health and Medicine Division, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Roundtable on Genomics and Precision Health, Sarah H. Beachy, Steve Olson, Amanda Wagner Gee, Siobhan Addie
and Medicine National Academies of Sciences, Engineering, Health and Medicine Division, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Carolyn Shore, Amanda Wagner Gee, Theresa Wizemann
and Medicine National Academies of Sciences, Engineering, Institute of Medicine, Board on Health Care Services, Committee on the State of the Science in Ovarian Cancer Research
and Medicine National Academies of Sciences, Engineering, Institute of Medicine, Board on Health Care Services, Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies, Harold L. Moses, Jonathan K. Phillips, Laurene A. Graig
Institute of Medicine, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Roundtable on Value and Science-Driven Health Care, Rebecca A. English, Julia Sanders, Claudia Grossmann