BioCentury reports that the FDA is seeking comments on approaches to make available to non-FDA experts and other interested parties de-identified and masked subject level clinical trial data derived from regulatory applications. According to the notice published in the Federal Register, the agency said the proposal is driven by its "desire to improve the product development process," noting that data may be useful "to address key hurdles in drug development" like validating new trial endpoints or clarifying how products work in different diseases. FDA also noted that pooled data can also be used to identify and analyze safety issues.
FDA is seeking input on strategies to minimize the ability to identify specific products, including making available certain data from a random sample of patients or pooling data for a number of products within a product class. The agency is also seeking input on how to mask data and limitations to making the masked data available, as well as input on de-identifying data. Additionally, FDA is seeking input on situations where disclosing masked data would be the most useful to advance public health. FDA said its proposal does not address making available unmasked safety and efficacy data that can be linked to a specific, identified application, including full study reports. The agency also said it "will not make available business-related confidential commercial information contained in product applications." Comments are due Aug. 3.
By the end of June, EMA is slated to publish a draft policy for public consultation providing more details on its plan to proactively release patient-level clinical data for approved drugs.