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.
Kernan WN, Viscoli CM, Varughese MC. Litigation Seeking Access to Data From Ongoing Clinical TrialsA Threat to Clinical Research. JAMA Intern Med. 2014;174(9):1502-1504. doi:10.1001/jamainternmed.2014.3248