Most Research Contracts Fail To Follow Conflict-of-Interest Guidelines, NEJM Study Finds

Most research contracts between academic institutions and pharmaceutical companies that fund clinical trials do not follow guidelines issued last year to prevent bias and conflict of interest in published research, according to a study in today's issue of the New England Journal of Medicine, the Wall Street Journal reports. For the study, researchers at Duke University surveyed 108 research institutions between November 2001 and January 2002 to determine if their clinical trial contracts with drug makers adhered to guidelines issued by the International Committee of Medical Journal Editors in September 2001. The study found that the committee's recommendations have "largely been ignored" and determined that in clinical trials there is a "general trend of academic independence compromised by business interests," the Journal reports (Zimmerman, Wall Street Journal, 10/24). "What the institutions have told us is, they feel almost powerless in these contracts," Dr. Kevin Schulman, lead author of the study, said (AP/Baltimore Sun, 10/24). According to survey respondents, 2% of contracts with drug makers established a committee-recommended independent executive committee to oversee the design and conduct of clinical trials, and only 1% of contracts established a data and safety monitoring board. In addition, only 1% of contracts implemented a recommendation that researchers at one medical site have access to clinical data at other medical sites participating in the trial (Wall Street Journal, 10/24). Fewer than 1% of contracts stipulated that trial results would be published and that an independent committee would have control of that process (AP/Baltimore Sun, 10/24).

"There are dangers here," Schulman said, adding, "Our findings suggest that a re-evaluation of the process of contracting for clinical research is urgently needed." The study did not determine if specific patients were injured because of the failure to follow the guidelines and did not document specific cases in which drug makers refused to publish results or shielded researchers from seeing trial data, the Journal reports. Responding to the study, the Pharmaceutical Research and Manufacturers of America said that they recently issued "new principles for the conduct of clinical trials and communication of trial results," the Journal reports (Wall Street Journal, 10/24). An abstract of the study is available online. NPR's "All Things Considered" yesterday reported on the NEJM study (Hamilton, "All Things Considered," NPR, 10/23). The full segment is available in RealPlayer online.