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FDA Concerned Over Clinical Trials Transparency

Jul 16, 2014

United States medical device regulators have scheduled a public hearing concerning keeping the results of cardiovascular outcomes trials (CVOTs) confidential until they are completed.

The meeting was discussed by the U.S. Food and Drug Administration (FDA) in a July 14, 2014 Federal Register notice, according to the Regulatory Affairs Professionals Society (RAPS). The trial is meant to ease outstanding regulatory concerns concerning product safety.

Generally, regulators mandate firms to conduct additional clinical trials to assess risks; however, these trials are time consuming and costly. Since the mid-2000s, the agency has been moving those trials into the post-market setting, enabling firms to market their products if they complete the mandatory trials by pre-specified dates. In some cases, according to the FDA, some trials "are not large enough to assess the risk of rare serious events such as heart attacks, strokes, or death," RAPS reported.

Large CVOTs are typically conducted to assess risks as a condition of approval and are often used in specific drug classes, such as diabetes medications. In some cases, drugs are approved on the condition that at CVOT be conducted, including the diabetes drugs Afrezza, Farxiga, and Tanzeum, RAPS wrote. But, these trials are of concern to the agency. CVOTs are intended to assess serious risks, which may lead to new safety restrictions or the drug being removed from the market; therefore, firms often conduct "interim" data analyses to generate preliminary findings. The findings may constitute early evidence that a drug is safe or that its risks outweigh its benefits in certain cases. In its Federal Register notice, the FDA indicated that interim data publication may be problematic.

Worldwide, regulators have indicated that "all staff involved in the conduct of the trial should remain blind to the results of such [interim] analyses because of the possibility that their attitudes to the trial will be modified and cause changes in the characteristics of patients to be recruited or biases in treatment comparisons," according to the FDA, which quoted the International Conference on Harmonization's (ICH) E9 Statistical Principles for Clinical Trials. The FDA recommends an Independent Data Monitoring Committee (DMC) ensure interim results do not interfere with ongoing care, instead of the use of trial investigators, RAPS reported.

Sometimes interim results are widely published and the FDA has indicated that investigators may learn of a trial. "Sponsors and other interested parties with access to interim data may have difficulty managing the remainder of the trial in an objective manner, particularly if changes to the trial protocol are needed for other reasons," the agency wrote, RAPS indicated.

The Federal Food, Drug and Cosmetic Act (FD&C Act) requires summaries of the interim data conducted for post-marketing studies "be made available immediately for public disclosure," which means that keeping the results from investigators is increasingly more challenging. As are situation in which one, ongoing trial is used to substantiate approval, as well as to generate post-approval data on cardiovascular risks. When this occurs, some information becomes available to investigators, including the drug's relative risk ratio, RAPS explained.

The FDA is now seeking public input concerning when and how to publicly disclose data and if alternative trial designs may be appropriate in post-market situations.

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