On June 4th, the FDA announced that it will call for public comments on its proposal to make available clinical and pre-clinical data. The proposal is consistent with the FDA’s push for full transparency, specifically to help regulatory science in the area of devices, drugs and biologics.
The FDA indicates the goal is to would be to allow outside experts to access data with research value in way that would protect privacy and commercial investment for product sponsors.
The FDA’s request for public comment includes the following questions:
- What factors should be considered in masking study data (e.g., data fields from regulatory submissions to remove or modify, a number of different products to pool within a product class)?
- What limitations, if any, should there be on the Agency’s ability to make available the masked data as described previously?
- Are there any additional factors FDA should consider in de-identifying data in addition to FDA’s requirement to remove any names and other information (e.g., birth date, death date, local geographic information, contact information) which would identify patients or research subjects before disclosing information?
- Would regulatory changes facilitate implementation of such a proposal, and if so, what changes would be most useful?
- Which situations do you believe disclosing masked data would be most useful to advance public health?
The proposal does appear to go as far as an initiative of the European Medicines Agency that would have full, patient-level clinical data published (for drugs trials only) once the product approval process has been completed. However, a key distinction between the FDA’s proposal and EMA’s initiative is the FDA’s emphasis on de-identifying and masking the data. The FDA also has a specific intention for how the data should be used: to help facilitate future product development.
What are your thoughts on the FDA’s ongoing effort for more transparency? Will providing this information help spur regulatory science in the device, drug and biologics area? Share your thoughts below.
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