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Litigation seeking access to data from ongoing clinical trials: a threat to clinical research
Walter N Kernan1, Catherine M Viscoli1, Mathew C Varughese2
1Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
Abstract:
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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