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FDA Meeting Will Consider Issues of Clinical Trial Transparency

Filed July 16th, 2014 Cynthia Diaz-Shephard

Next month, the Food and Drug Administration (FDA) will hold a public hearing to discuss how the results of cardiovascular outcomes trials (CVOTs) can be kept confidential until the trials are completed so as not to adversely affect the trial.

These trials are undertaken to address outstanding regulatory concerns about the safety of a drug. Traditionally, the FDA has required the drug maker to conduct additional clinical trials to assess those risks prior to approval — but trials are costly and can take years to complete. In the last ten years, the FDA has increasingly shifted some trials to postmarket settings, allowing companies to market products on the condition that they finish the mandatory trials by specified dates, according to the Regulatory Affairs Professional Society (RAPS).
Large CVOTs assess the risks of events such as heart attacks, strokes, or death as a condition of approval and are common for certain classes of drugs, including diabetes medications. Three diabetes drugs, Afrezza, Farxiga, and Tanzeum all received approval on condition that the drug makers conduct CVOTs to evaluate cardiovascular risks, RAPS reports.

Drug companies regularly conduct interim analyses of data to generate preliminary findings. But interim findings can be problematic and can affect an ongoing trial. “Sponsors and other interested parties with access to interim data may have difficulty managing the remainder of the trial in an objective manner,” according to the FDA. For this reason the FDA recommends that an Independent Data Monitoring Committee (DMC) review the interim results instead of trial investigators. But the Federal Food, Drug and Cosmetic Act (FD&C Act) calls for summaries of the interim data conducted for postmarketing studies to “be made available immediately for public disclosure,” according to RAPS, making it difficult to keep results from investigators.

In the meeting announcement in the Federal Register, the FDA says it wants to solicit input on how and when to disclose data to the public, and whether alternative trial designs might be appropriate for use in postmarket settings.

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