Article questions contract research

A "Health Policy Report" published in the New England Journal of Medicine (vol. 342, no. 20) questions the relationship between the pharmaceutical industry and contract research organizations in clinical research.

The report, written by Thomas Bodenheimer, was compiled from interviews with six pharmaceutical executives, 12 clinical investigators, nine people from university research offices, two physicians from CROs, eight people who have studied the process of clinical drug trials and two professional writers. According to the author, each interview consisted of standard questions in addition to an opportunity for the interviewee to discuss the industry-investigator relationship in a general way.

The report was conducted because of a pharmaceutical industry shift from using academic medical centers for research to using contract research organizations, which are often much faster. According to the report, the percentage of industry research monies going to academic centers for clinical research has fallen from 80% in 1991 to 40% in 1998, prompting concern that clinical bias may be affected.

"Although academic-industry drug trials have been tainted by the profit incentive, they do contain the potential for balance between the commercial interests of industry and the scientific goals of investigators," said Bodenheimer in his report. "In contrast, trials conducted in the commercial sector are heavily tipped toward industry interests, since for-profit CROs and [site-management organizations], contracting with industry in a competitive market, will fail if they offend their funding sources."

Continued Bodenheimer, "The pharmaceutical industry must appreciate the risks inherent in its partnership with the commercial drug-trial sector: potential public and physician skepticism about the results of clinical drug trials and a devaluation of the insights provided through close relationships with academic scientists."

Bodenheimer did offer ideas on how to resolve the problems of bias in clinical drug trials. "An essential ingredient of any solution is increasing the independence of investigators to conduct and publish their research," he said. "The rise of the commercial sector ... appears to be moving drug trials in the opposite direction." PR