| N Engl J Med 2002 Oct 24;347(17):1335-41 | Related Articles, Links |
Comment in:
A national survey of provisions in clinical-trial
agreements between medical schools and industry sponsors.
Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark
DB, Califf RM.
Center for Clinical and Genetic Economics, Duke University Medical Center,
Durham, NC, USA. kevin.schulman@duke.edu
BACKGROUND: Concerned about threats to the integrity of clinical trials in a
research environment increasingly controlled by private interests, the
International Committee of Medical Journal Editors (ICMJE) has issued revised
guidelines for investigators' participation in the study design, access to
data, and control over publication. It is unclear whether research conducted
at academic institutions adheres to these new standards. METHODS: From
November 2001 through January 2002, we interviewed officials at U.S. medical
schools about provisions in their institutions' agreements with industry
sponsors of multicenter clinical trials. A subgroup of the respondents were
also asked about coordinating-center agreements for such trials. RESULTS: Of
the 122 medical schools that are members of the Association of American
Medical Colleges, 108 participated in the survey. The median number of
site-level agreements executed per institution in the previous year was 103 (interquartile
range, 50 to 210). Scores for compliance with a wide range of provisions--from
ensuring that authors of reports on multicenter trials have access to all
trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan
for data collection and monitoring (10 percent [interquartile range, 1 to
50])--demonstrated limited adherence to the standards embodied in the new
ICMJE guidelines. Scores for coordinating-center agreements were somewhat
higher for most survey items. CONCLUSIONS: Academic institutions routinely
engage in industry-sponsored research that fails to adhere to ICMJE guidelines
regarding trial design, access to data, and publication rights. Our findings
suggest that a reevaluation of the process of contracting for clinical
research is urgently needed. Copyright 2002 Massachusetts Medical Society
PMID: 12397192 [PubMed - indexed for MEDLINE]