FDA PROPOSES SHARING CLINICAL DATA (Orthopedics This Week)
The FDA wants to share your clinical data with “non-FDA experts and other interested parties.”
The agency says data gained from patients participating in clinical trials should be “maximized” for the benefit of society. So the agency is proposing to share clinical and preclinical data derived from marketing applications after de-identifying and masking that data.
Safeguard Commercial Investments
However, the agency says it wants to do it in a way that would “both safeguard the privacy interests of patients enrolled in clinical trials, and appropriately protect the commercial investments of sponsors.”
The proposal contemplates the availability of certain data after appropriate steps have been taken to de-identify it and remove the data’s link to a specific product, study, or application.
The proposal, according to the FDA, does not pertain to unmasked safety and effectiveness data, (i.e., data that can be linked to a specific, identified application) including full study reports; the circumstances under which the disclosed information is already specifically set forth in the Federal Food Drug and Cosmetic Act and FDA’s regul...
