Ethics of clinical trials

If you participate in clinical trials, should you know the results? This question may not be that easy to answer. In a commentary about cancer clinical trials, Maurie Markman, M.D., from the University of Texas M. D. Anderson Cancer Center, discusses the potential pitfalls of full disclosure.

Dr. Markman advocates a revised informed consent strategy that balances the subject’s right to know the results of the study and an individual patient’s right to know how the data will specifically impact him or her. This strategy includes pre-study education about the meaning of trial data as statistical probabilities pertaining to general populations rather than a specific individual; the risk that trial data will have no benefit for the individual and may in fact demonstrate poor prognosis; the subjects’ choice to receive trial data at the end of the study; and possibility that investigators may decide that trial data is of no relevance to the individual participant and not share the data.

One point about full disclosure ignores the fact that the participant remains a patient, regardless of the outcome. Long term, patients may be impacted by knowing if the test treatment they received during the study was less effective.

Also, which information should be disclosed and in which format? Do we disclose the raw data, or do we disclose basic analysis, or what? Should we have independent panels that release the reports? How about (strict) guidelines about what the disclosure should entail?

So, a lot of questions to ponder about an important subject. What do you think we should do?

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