In this issue of JAMA Internal Medicine, Kernan et al1 chronicle Yale University’s experience responding to a subpoena for data from an ongoing, double-blind, placebo-controlled trial of pioglitazone. The subpoena arose from litigation brought by Sara J. Kincaid,2 who believed she had been injured by pioglitazone but who was not a clinical trial participant. Yale’s legal team was troubled because they believed that releasing the data would compromise the integrity of the trial and threaten the investigators’ scientific interests.
Mello MM, Cohen IG. Clinical Trials and the Right to Remain Silent. JAMA Intern Med. 2014;174(9):1505-1506. doi:10.1001/jamainternmed.2014.2341