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(Stroke. 2003;34:1041.)
© 2003 American Heart Association, Inc.

Comments, Opinions, and Reviews

Recommendations for the Relationship Between Sponsors and Investigators in the Design and Conduct of Clinical Stroke Trials

Geoffrey A. Donnan, MD; Stephen M. Davis, MD Markku Kaste, MD for the International Trial Subcommittee of the International Stroke Liaison Committee, American Stroke Association

From the National Stroke Research Institute and Department of Neurology, Austin & Repatriation Medical Centre and University of Melbourne, West Heidelberg, Victoria, Australia (G.A.D.); Department of Neurology, Royal Melbourne Hospital and University of Melbourne, Parkville, Victoria, Australia (S.M.D.); and Department of Neurology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland (M.K.).

Correspondence to Dr Geoffrey A. Donnan, National Stroke Research Institute, Austin & Repatriation Medical Centre, Level 1, Neurosciences Bldg, Gate 10, Banksia St, West Heidelberg, Victoria 3081, Australia. E-mail donnan{at}austin.unimelb.edu.au

Background— As increasing numbers of clinical trials are being conducted worldwide, there has been concern about the relationship between the sponsors and investigators. Both parties need benchmarks or recommendations to act as a reference point when trials are initiated and conducted. These recommendations are designed to fulfill this role.

Summary of Comment— A series of meetings of the International Trial Subcommittee of the International Stroke Liaison Committee, American Stroke Association, were conducted to review a series of draft recommendations that were then modified on the basis of the experience of the committee in the conduct of clinical trials. Consensus was reached on all points of the final document. The recommendations represent the opinions of the authors and do not necessarily reflect the views of the American Stroke Association. The document contains sensible recommendations concerning required sponsor company qualities, trial management structure, protocol development, trial conduct, data management, blinding, data analyses, publication, remuneration, and conflict of interest issues.

Conclusions— The recommendations should provide a simple and practical benchmark for both investigators and sponsors in the conduct of clinical trials. Although designed for trials involving therapies for stroke, the framework allows generalization to other disciplines.

Key Words: clinical trials • drug industry • health planning guidelines • research support

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