Next month, the Food and Drug Administration (FDA) will hold a public hearing about maintaining confidentiality of preliminary drug trial results until the trials are completed so as not to adversely affect the trial.
Cardiovascular outcomes trials (CVOTs) are undertaken to address outstanding regulatory concerns about the safety of an approved drug. The FDA has traditionally required drug makers to conduct additional clinical trials to assess those risks prior to approval. But clinical trials are costly and take years to complete, so in the last ten years, the FDA has increasingly shifted trials to the postmarket, allowing a company to market a drug on the condition that mandatory trials are completed by specified dates, according to the Regulatory Affairs Professional Society (RAPS).
Large CVOTs assess the risks of heart attacks, strokes, or death as a condition of approval. CVOTs are common for certain classes of drugs, including diabetes medications, and three diabetes drugs – Afrezza, Farxiga, and Tanzeum –recently received approval on condition that the CVOTs be conducted, RAPS reports.
During a trial, drug companies regularly conduct interim analyses to generate preliminary findings. But preliminary findings have sometimes affected ongoing trials. “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 in postmarket studies to “be made available immediately for public disclosure,” according to RAPS, making it difficult to keep investigators from seeing, and possibly being influenced by, interim data.
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, RAPS reports.