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Hopkins faculty lead development of report to FDA on ethical, scientific issues related to 'post-market' clinical trials
Date:7/12/2010

prehensive and meaningful informed-consent process in place, and one that continues over the course of the trials. Specifically, participants should be promptly advised of developments such as new research findings or changes in clinical practice that could affect their willingness to continue to accept the risks associated with a trial.

"The letter report was designed to provide general, broad guidance about some of the ethical issues that need to be taken into account by the F.D.A. in requiring post-market safety studies," says Ruth Faden, Ph.D., M.P.H., the committee's co-chair and the director of the Johns Hopkins Berman Institute of Bioethics.

The other co-chair is Steven Goodman, M.D., Ph.D., a professor of oncology in the Division of Biostatistics at the Johns Hopkins Kimmel Cancer Center and a core member of the Berman Institute faculty as well. Goodman is editor-in-chief of Clinical Trials: Journal of the Society for Clinical Trials and serves on the society's board of directors.

"The post-marketing context poses more difficult ethical and design challenges than we could address in this letter report," says Faden, a member of the Institute of Medicine (IOM). "We plan to take on these challenges in more detail in our full report."

The more immediate report responds to one of several questions that the F.D.A. asked IOM to explore in a review of ethical and scientific issues related to studying the safety of drugs on the market. The agency requested an initial report on the ethical issues in advance of a meeting it will hold July 13 and 14 to discuss the case of the diabetes drug Avandia.

The report covers some of the issues at play in the case but does address the specific controversies surrounding a large-scale clinical trial launched by the drug's maker, GlaxoSmithKline PLC.

A more detailed analysis of the issues discussed in the report, as well as their implications and effects, will be presented
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Contact: Michael Pena
mpena@jhsph.edu
410-625-7872
Johns Hopkins Medical Institutions
Source:Eurekalert

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