There has been clamor recently to disclose the results of study findings with participants after the completion of the study. However, a commentary published in the April 1, 2006 issue of CANCER, a peer-reviewed journal of the American Cancer Society, says that such disclosures may actually do more harm than good as they cause unnecessary psychological stress to patients.
Maurie Markman, M.D., of the University of Texas M. D. Anderson Cancer Center in Houston, says that this practice contravenes the ethical considerations that oblige doctors to do no harm to the patients. In the commentary in CANCER, Markman says that even at the end of a study, the patient remains a patient and after some years might consider the treatment rendered in the study as ineffective. The patient will then be obliged to think that if a "better" treatment was given, perhaps the outcome might have been different. Dr. Markman says that revising the informed consent strategy to tell the patient how the study might affect his/her health might be the way to go. This "pre-study education" could also tell that the drug in question might not confer better prognosis anyway. This approach "will preserve a research subject's right to be provided study findings, while at the same time responding to an individual's legitimate wish to specifically focus on data which is relevant to his/her future management," says Dr. Markman.
Article: "Providing Research Participants with Findings from Completed Cancer-Related Clinical Trials: Not Quite as Simple as it Sounds," Maurie Markman, CANCER; Published Online: February 27, 2006 (DOI: 10.1002/cncr.21757); Print Issue Date: April 1, 2006.
Contact: David Greenberg
John Wiley & Sons, Inc.