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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

Amid growing concerns about clinical trials for drugs that have been approved by the F.D.A. but are later linked to serious health risks, an independent committee at the Institute of Medicine led by two professors from Johns Hopkins University has developed a conceptual framework to guide the agency through the tough decision of ordering such controversial "post-market" drug-safety trials.

The recommendations of the committee, requested by the Food and Drug Administration, lay out a set of considerations that the F.D.A. can reference to ensure that clinical trials uphold ethical duties to trial participants. The committee also stresses that the agency be accountable to the public in its decision-making processes.

Presented on July 9 in a letter report to the F.D.A., the framework is organized around these recommendations:

  • The F.D.A. should determine if questions about possible risks or the risk-benefit balance of a drug or vaccine already on the market are serious enough to justify a policy decision, such as whether to revise the product's label.

  • A randomized, controlled trial of a drug linked to serious side effects should be conducted only when the existing scientific evidence and any evidence from new observational studies still do not supply the F.D.A. with enough data to make responsible policy decisions.

  • The agency should use "regulatory-science" principles and practices that emphasize public accountability and transparency when determining the need for a policy decision or the need for new knowledge to support a policy decision.

  • Such post-marketing trials to assess the safety and efficacy of approved drugs should be properly designed so that they minimize risk to patients and monitor risks on an ongoing basis. Any risks should first be judged as "acceptable" by appropriate oversight bodies.

  • Lastly, the F.D.A. and relevant oversight agencies should ensure that such trials have a com
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Contact: Michael Pena
mpena@jhsph.edu
410-625-7872
Johns Hopkins Medical Institutions
Source:Eurekalert

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