In this article, Catalyst comments on FDA’s developing plans related to collection and analysis of demographic subgroup data in clinical trials. Under FDASIA, the agency is required to develop an action plan on demographic subgroup participation in trials by August 2014.

Catalyst’s Nancy Bradish Myers, a former special assistant/senior strategic advisor to the FDA’s acting deputy commissioner for operations, notes that “while guidance is usually helpful, developing and publishing it is a slow process.”

She goes on to discuss personalized medicine, noting that tailoring treatments based on genomics is “moving at light speed” and by its “nature defining the most appropriate subpopulations.” Therefore, “any guidance contemplated should be crafted to ensure that it focuses on what is truly helpful to the relevant subpopulations and does not add unnecessary costs or delay the drug development process.”

Further FDA guidance unlikely to move the needle on collecting demographic subgroup data – experts
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