CMAJ • November 22, 2005; 173 (11). doi:10.1503/cmaj.1050172.
© 2005 CMA Media Inc. or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
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Letters

Conforming to ICMJE principles

Scott A. Halperin, David Scheifele, Bernard Duval and Brian Ward

On behalf of the Canadian Association for Immunization Research and Evaluation (CAIRE), Vancouver, BC

There is increasing concern about interactions between academic investigators and the pharmaceutical industry, particularly relating to financial and other conflicts of interest, access by investigators to all research data and the ability of investigators to take full responsibility for the results of studies funded by industry. The latter 2 concerns led to a revision of the guidelines for the submission of articles to biomedical journals published in 2001 by the International Committee of Medical Journal Editors (ICMJE).1 Four years after publication of that commentary, clinical trial agreements between academic medical centres and industry still do not conform to the ICMJE principles.2,3,4

The Canadian Association for Immunization Research and Evaluation (www.caire.ca), a network of investigators from academia and public health, has developed a set of guidelines for industry-sponsored clinical trial and epidemiology contract research in Canada in collaboration with 6 multinational vaccine manufacturers.5 These guidelines describe the roles of the academic and public health investigator in protocol development, access to data, data management, data analysis, creation of the study report and publication in peer-reviewed journals. The guidelines conform to the recommendations of the ICMJE and aim to ensure that the academic or public health investigators have full and unrestricted access to data and play a leading role in the publication of study results. We hope that these guidelines will address the deficiencies documented in recent evaluations of clinical trial agreements and will serve as a model for the interaction between academia, public health and the pharmaceutical industry.

REFERENCES

  1. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship and accountability. CMAJ 2001;165(6):786-8.[Free Full Text]
  2. Schulman KA, Seils DM, Timbie JW, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002;347:1335-41.[Abstract/Free Full Text]
  3. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005;352:2202-10.[Abstract/Free Full Text]
  4. Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med 2005;352:2160-2.[Free Full Text]
  5. Halperin SA, Scheifele D, Duval B, et al. Canadian Association for Immunization Research and Evaluation (CAIRE) Guidelines for Industry Sponsored Clinical Trial and Epidemiology Contract Research. Hum Vaccines 2005;1(4):140-2.




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