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Invited Commentary
September 2014

Clinical Trials and the Right to Remain Silent

Author Affiliations
  • 1Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts
  • 2Harvard Law School, Boston, Massachusetts
JAMA Intern Med. 2014;174(9):1505-1506. doi:10.1001/jamainternmed.2014.2341

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.