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Litigation seeking access to data from ongoing clinical trials: a threat to clinical research.

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.

SUBMITTER: Kernan WN 

PROVIDER: S-EPMC5758866 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Litigation seeking access to data from ongoing clinical trials: a threat to clinical research.

Kernan Walter N WN   Viscoli Catherine M CM   Varughese Mathew C MC  

JAMA internal medicine 20140901 9

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 Co  ...[more]

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