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Title: Recommendations for the relationship between sponsors and investigators in the design and conduct of clinical stroke trials.
Austin Authors: Donnan, Geoffrey A ;Davis, Stephen M;Kaste, Markku
Institutional Author: International Trial Subcommittee of the International Stroke Liaison Committee, American Stroke Association
Affiliation: National Stroke Research Institute, Department of Neurology, Austin & Repatriation Medical Centre, University of Melbourne, West Heidelberg, Victoria, Australia
Issue Date: 20-Mar-2003
Publication information: Stroke; A Journal of Cerebral Circulation 2003; 34(4): 1041-5
Abstract: 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.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.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.
Gov't Doc #: 12649514
DOI: 10.1161/01.STR.0000063142.39828.67
Journal: Stroke
Type: Journal Article
Subjects: Clinical Trials as Topic.standards
Drug Industry
Research Design
Research Personnel
Stroke.drug therapy.therapy
Appears in Collections:Journal articles

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