“The primary intent of these recommendations is to improve the quality, consistency and transparency of data regarding the performance of medical devices within specific age, race and ethnic groups,” reads the Federal Register posting.
As part of the Food and Drug Administration Safety and Innovation Act, the agency is required to alert Congress about the range of clinical trial data it receives from researchers. The current guidance for which the FDA wants commentary outlines expectations for patient enrollment, data analysis and reporting of a number of demographic factors.
The guidance is designed to encourage thorough data collection on patient participants in approved studies, offer direction for interpreting study outcomes based on that fine-grained data and specify ways to include that data in the summaries and labeling of treatments that make it to market.
The comment period is open through Sept. 19, 2016, and instructions for submission may be found here.
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