A recent push to share study findings with patients after they complete treatment in clinical trials may actually do more harm than good by exposing study participants to unnecessary psychological stress, according to a new commentary. Published in the April 1, 2006 issue of CANCER (http://www.interscience.wiley.com/cancer-newsroom), a peer-reviewed journal of the American Cancer Society, the commentary suggests investigators have an ethical obligation to minimize harm to participants by providing participants only the study data that will directly benefit their future care, and by giving them an option to read and discuss the results as they pertain to their own disease management.

Current ethical practices in research emphasize protecting patient rights before and during a study. Recent ethical discussions have turned to the rights of study participants to learn the results of study findings after the trial is completed. Ethicists have proposed that participants be given a summary of study findings at the conclusion of a study to know how the study and their participation will affect future patients. Some data suggests that subjects really do want to know the study outcome.

In his commentary, Maurie Markman, M.D., of the University of Texas M. D. Anderson Cancer Center in Houston, argues that disclosing the outcome of the study may, in fact, do more harm than the intended good for the patient. Moreover, this approach ignores the fact that at the conclusion of the study, the participant remains a patient. For example, a study participant who receives what turns out to be a less effective treatment may be negatively impacted years later from the knowledge that the treatment they received was not the best, and that as a result their prognosis may be poorer than if they received the "better" treatment. Moreover, there is little the patient can do to change the past treatment.

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Contact: David Greenberg
dgreenbe@wiley.com
201-748-6484
John Wiley & Sons, Inc.
27-Feb-2006

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