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A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

Publication ,  Journal Article
Schulman, KA; Seils, DM; Timbie, JW; Sugarman, J; Dame, LA; Weinfurt, KP; Mark, DB; Califf, RM
Published in: N Engl J Med
October 24, 2002

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.

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 24, 2002

Volume

347

Issue

17

Start / End Page

1335 / 1341

Location

United States

Related Subject Headings

  • United States
  • Schools, Medical
  • Research Support as Topic
  • Publications
  • Interinstitutional Relations
  • Guidelines as Topic
  • General & Internal Medicine
  • Drug Industry
  • Data Collection
  • Conflict of Interest
 

Citation

APA
Chicago
ICMJE
MLA
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Schulman, K. A., Seils, D. M., Timbie, J. W., Sugarman, J., Dame, L. A., Weinfurt, K. P., … Califf, R. M. (2002). A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med, 347(17), 1335–1341. https://doi.org/10.1056/NEJMsa020349
Schulman, Kevin A., Damon M. Seils, Justin W. Timbie, Jeremy Sugarman, Lauren A. Dame, Kevin P. Weinfurt, Daniel B. Mark, and Robert M. Califf. “A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.N Engl J Med 347, no. 17 (October 24, 2002): 1335–41. https://doi.org/10.1056/NEJMsa020349.
Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med. 2002 Oct 24;347(17):1335–41.
Schulman, Kevin A., et al. “A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.N Engl J Med, vol. 347, no. 17, Oct. 2002, pp. 1335–41. Pubmed, doi:10.1056/NEJMsa020349.
Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med. 2002 Oct 24;347(17):1335–1341.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 24, 2002

Volume

347

Issue

17

Start / End Page

1335 / 1341

Location

United States

Related Subject Headings

  • United States
  • Schools, Medical
  • Research Support as Topic
  • Publications
  • Interinstitutional Relations
  • Guidelines as Topic
  • General & Internal Medicine
  • Drug Industry
  • Data Collection
  • Conflict of Interest