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Special Communication
September 2014

Litigation Seeking Access to Data From Ongoing Clinical Trials: A Threat to Clinical Research

Author Affiliations
  • 1Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 2Office of the General Counsel, Yale University, New Haven, Connecticut
JAMA Intern Med. 2014;174(9):1502-1504. doi:10.1001/jamainternmed.2014.3248

Researchers conducting randomized clinical trials may find themselves subject to legal subpoenas for interim data. When a subpoena demands premature disclosure of unblinded data, there is potential for damage to the scientific integrity and reputation of the on-going trial. We describe herein general issues raised by subpoenas for trial data and the particular case of a 2012 subpoena served on investigators from Yale University who were successful in winning reprieve from Connecticut Superior Court.

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