FDA fine-tuning its position on trials controlled by placebo.(Placebos)

Publication: Bioresearch Monitoring Alert

Publication Date: 01-DEC-05

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PHILADELPHIA -- A clinical trial characterized as a "medical experiment" is perhaps the most inflammatory accusation being made in the courts today, and the fuel for this fire is placebo-controlled trials, attorneys told CBI Dec. 4.

In clinical trials law suits, plaintiffs' attorneys are asking pointed questions about why a placebo control was used, and thus treatment withheld from a particular subject, when a comparator trial might have yielded the information necessary for drug approval.

A key reason is that FDA is seen to be a proponent of placebo-controlled trials. But speakers argued that this largely is an industry misperception, and that a careful examination of regulatory language...

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