The Institute of Medicine (IOM) released a letter report outlining “a conceptual framework to help the U.S. Food and Drug Administration evaluate the ethical issues involved in determining whether companies should start or continue clinical trials on approved drugs and in ensuring that these studies are ethically conducted.” The proposed framework “underscores the importance of FDA’s decision-making processes and study design considerations,” and notes that FDA “should ensure that any randomized, controlled trial to evaluate the efficacy and safety of an approved drug that is suspected of causing serious adverse events is conducted only when the existing evidence and any evidence from new observational studies would be insufficient to enable the agency to make responsible policy decisions.  The agency should determine that questions about a drug’s possible risks or risk-benefit balance rise to the level of requiring a policy decision, such as whether to revise the product’s label…”

Te framework also notes that “…FDA should make sure that trials are appropriately designed to resolve uncertainties about efficacy and safety and to minimize risks to participants. Risks should be judged acceptable by appropriate oversight bodies, and participants and studies should be continuously monitored to assure that the risks continue to be acceptable. The process of informed consent should continue over the course of the trials, and participants should be promptly advised of substantial changes in clinical practice or professional standards and new research findings that could affect their willingness to accept the risks associated with a trial.  FDA should apply principles and practices of regulatory science to ensure that its policy decisions reflect the best available scientific evidence and analytic techniques and that they are made in a transparent way to ensure public accountability.”

The report responds to one of several questions FDA asked IOM to explore in a review of ethical and scientific issues related to studying the safety of drugs on the market.  http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12948

The report is available at: http://www.nap.edu/catalog.php?record_id=12948