Following significant pressure to promote sex-specific clinical research and product labeling, most recently from Congress and interest groups, FDA recently issued a final guidance on Evaluation of Sex-Specific Data in Medical Device Clinical Studies in combination with its FDASIA Section 907 Action Plan. Responding to decades of concern about the disparities in clinical data, the final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents. The action plan delineates 27 action items across three overarching priorities: data quality, subgroup participation, and data transparency. Certain medical products may elicit different responses in women than men, and these variables may affect the safe and effective use of medical devices. The final guidance outlines specific recommendations for considering sex and other variables during the study design stage, improving consistency of analysis, and reporting information on demographics in labeling and other public documents. According to an announcement made by Commissioner Hamburg on the same day, some action items are likely to be achieved within a year, while others may take as long as three to five years to complete. Critics say FDA's plans for greater inclusion in clinical trials are still lacking because they do not include pregnant women and children.
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