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July 17, 2002

Informing Clinical Trial Participants About Study Results

Author Affiliations

Author Affiliations: Department of Adult Oncology, Dana-Farber Cancer Institute, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.

JAMA. 2002;288(3):363-365. doi:10.1001/jama.288.3.363

Of the 1.3 million individuals diagnosed with cancer each year in the United States,1 a substantial minority participate in clinical trials.2,3 When patients agree to enter these trials, they expect their physicians to provide full and detailed information about the study. In addition, the success of the research may be influenced by how well patients are informed.4 Following completion of a clinical trial, participants are not routinely informed about the aggregate study results unless this information would influence their future care. However, anecdotal experience suggests that many patients who participate in clinical trials are interested in the experience of other patients enrolled in the study and in learning about the aggregate results. A recent consensus conference recommended that the results of clinical trials should be made available to participants and suggested that providing participants with results, both positive and negative, should be considered the "ethical norm."5 Currently, there is clear disparity between this recommendation and what actually occurs. This article examines the implications of offering trial results to study participants and the steps necessary before results could be routinely provided. Clinical trials of cancer therapies are used as an example, although the issues may extend to many types of clinical research.

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