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Special Communication |

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

Walter N. Kernan, MD1; Catherine M. Viscoli, PhD1; Mathew C. Varughese, JD2
[+] 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.
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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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