Compact versus Contract — Industry Sponsors' Obligations to Their Research Subjects

• Published in: The New England journal of medicine Vol. 356; no. 26; pp. 2737 - 2743
• Main Authors: Mello, Michelle M, Joffe, Steven
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 28.06.2007
• Subjects: Academic Medical Centers - ethics; Academic Medical Centers - legislation & jurisprudence; Clinical trials; Clinical Trials, Phase II as Topic - legislation & jurisprudence; Conflict of Interest; Consent; Consent Forms - legislation & jurisprudence; Contract Services - legislation & jurisprudence; Contracts - ethics; Contracts - legislation & jurisprudence; Corporate sponsorship; Drug Industry - ethics; Drug Industry - legislation & jurisprudence; Federal court decisions; Humans; Kentucky; Legal arguments; Therapeutic Human Experimentation - ethics; Therapeutic Human Experimentation - legislation & jurisprudence; United States; United States; Kentucky
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMhle067499

Research subjects in a clinical trial sued Amgen because they were not provided with experimental treatment after the trial was stopped early because of lack of efficacy and concerns about safety. The informed consent form promised continued treatment after the trial ended, but a U.S. Court of Appeals ruled in favor of Amgen, arguing that the consent form was a contract between the academic investigators and the subjects and was not binding on Amgen. Research subjects in a clinical trial sued Amgen because they were not provided with experimental treatment after the trial was stopped early. A U.S. Court of Appeals ruled in favor of Amgen. Public unease about industry's influence over clinical research has never been greater. Recent events have elevated concerns about financial ties among investigators, academic medical centers, and industry sponsors, 1 – 4 and disquieting findings have emerged about the legal relationships these entities form to conduct clinical trials. 5 – 8 Tort litigation brought by injured research subjects has accentuated the legal dimensions of clinical research relationships. 9 – 11 These areas of focus converged in Abney v. Amgen, an important case decided in March 2006 by the U.S. Court of Appeals for the Sixth Circuit. 12 The dispute centered on the legal obligation of an industry sponsor . . .