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Cover of Sharing Clinical Research Data

Sharing Clinical Research Data

Workshop Summary


Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-26874-5ISBN-10: 0-309-26874-5


Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, present challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets.

This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.


Rapporteurs: Steve Olson, Autumn S. Downey

This activity was supported by contracts between the National Academy of Sciences and AbbVie, Alzheimer's Association, American Academy of Nursing, American Association for Cancer Research, American Cancer Society, American College of Medical Genetics and Genomics, American Diabetes Association, American Heart Association, American Medical Association, American Society for Microbiology, American Society of Clinical Oncology, American Society of Human Genetics, Amgen Inc., Association of American Cancer Institutes, Association of American Medical Colleges, Blue Cross and Blue Shield Association, Bristol-Myers Squibb, Burroughs Wellcome Fund, C-Change, Celtic Therapeutics, LLLP, CeNeRx Biopharma, Centers for Disease Control and Prevention (Contract Nos. 200-2005-13434 and 200-2011-38807), CEO Roundtable on Cancer, College of American Pathologists, Critical Path Institute, Department of Health and Human Services' National Institutes of Health (NIH) (Contract Nos. HHSN261200900003C, HHSN2632012000074I, Order HHSN26300004 and TO#5, and N01-OD-4-2139, TO#189, TO#264, TO#275, and TO#276), Department of the Air Force (Contract No. FA7014-10-P-0072), Department of Veterans Affairs (Contract No. V101(93) P-2238), Doris Duke Charitable Foundation, Duke University, Eli Lilly and Company (Contract No. LRL-0028-07), Fast Forward, LLC, FasterCures, Food and Drug Administration (Contract Nos. HHSF22301028T and HHSF22301026T), Foundation for the National Institutes of Health, Friends of Cancer Research, GE Healthcare, Inc., Genetic Alliance, GlaxoSmithKline, Health Resources and Services Administration (Contract No. HHSH250201100119P), Janssen Research & Development, LLC (Contract No. ICD_457279), Johnson & Johnson Pharmaceutical Research and Development, LLC, The Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (Contract No. 20121257), Life Technologies, Lundbeck Research USA, March of Dimes Foundation, Merck & Co., Inc. (Contract No. CMO 2012-0075), Merck Research Laboratories, The Michael J. Fox Foundation for Parkinson's Research, National Coalition for Health Professional Education in Genetics, National Science Foundation (Contract No. OIA-0753701), National Society of Genetic Counselors, Northrop Grumman Health IT, Novartis Oncology, Novartis Pharmaceuticals Corporation, Oncology Nursing Society, One Mind for Research, Pfizer Inc. (Contract No. 140-N1818071), Sanofi-Aventis, Society for Neuroscience, Stanford University, and Wellcome Trust. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the project.

Suggested citation:

IOM (Institute of Medicine). 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press.

Copyright © 2013 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK131772PMID: 23700647DOI: 10.17226/18267


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