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Sharing Medicine
September 2017

Sharing Clinical Research Data—Finding the Right Balance

Author Affiliations
  • 1The Greenwall Foundation, New York, New York
  • 2Departments of Medicine and Health Research & Policy, Stanford University, Stanford, California
JAMA Intern Med. 2017;177(9):1241-1242. doi:10.1001/jamainternmed.2017.1926

Sharing full data from clinical trials has been extensively advocated to better understand the harms and benefits of current treatments, generate new hypotheses, and maximize knowledge gained through trial participants’ altruism. Several pharmaceutical companies and the European Medicines Agency, which licenses drugs in Europe, are now sharing clinical trial data.1 An Institute of Medicine report1 presented a framework and the International Committee of Medical Journal Editors issued a draft proposal for clinical trial data sharing. The National Institutes of Health have expanded requirements for registration of clinical trials, reporting of summary results, and data management plans.2 The Patient Centered Outcomes Research Institute has been working on a data sharing policy almost since its inception. Beyond clinical trials, researchers can study the effectiveness or safety of therapies via observational data collected in electronic health records within the US Food and Drug Administration (FDA) Sentinel Program, within research-oriented health care systems, and through the Patient-Centered Outcomes Research Network. In various precision medicine initiatives, patients are sharing with researchers data from personal devices and genomic sequencing of biospecimens.