Academic Medical Centers’ Standards for Clinical-Trial Agreements With Industry

Details

Author(s):
  • Michelle Mello
Publish Date:
May 26, 2005
Publication Title:
352 New England Journal of Medicine, pp. 2202-2210 .
Format:
Journal Article
Citation(s):
  • Michelle M. Mello, Brian R. Clarridge and David M. Studdert. Academic Medical Centers’ Standards for Clinical-Trial Agreements With Industry. 352 New England Journal of Medicine, pp. 2202-2210 (May 26, 2005).

Abstract

In September 2000, Immune Response, a biopharmaceutical company, filed a $7 million legal action against the University of California at San Francisco after researchers published negative findings from a clinical trial of the company's experimental acquired immunodeficiency syndrome (AIDS) vaccine, Remune. The investigators had refused to allow the company to insert its own statistical analyses into the manuscript. Immune Response demanded that the researchers not publish the article and withheld some of the data in an effort to dampen their publication prospects.The investigators succeeded in publishing but subsequently faced a legal battle that ended only after the university filed a counterclaim alleging that the contract between the parties gave the researchers permission to publish. The Remune case, other high-profile clashes between academic researchers and pharmaceutical sponsors, and recent controversies concerning the disclosure of unfavorable findings in studies of antidepressants in children and rofecoxib have elevated concerns about industry-sponsored trials. Because conflicts often turn on the language of the clinical-trial agreement, they illuminate the potential consequences of contractual provisions that restrict academic investigators' control over trials. Building on two previous studies, we sought to obtain detailed data about academic medical centers' standards and policies concerning restrictive provisions in clinical-trial agreements.