This post originally appeared on the News page of Leaders Engaged on Alzheimer’s Disease (LEAD Coalition). SWHR thanks the LEAD Coalition for its ongoing partnership.
The U.S. Food and Drug Administration (FDA) has published revised draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products (FDA-2024-D-4245). The guidance provides recommendations for increasing enrollment of female participants in clinical trials and non-interventional studies to help ensure the generalizability of results; analyzing and interpreting sex-specific data; and, including sex-specific information in regulatory submissions of medical products. Revisions follow an early 2025 public comment period, to which the LEAD Coalition and the Society for Women’s Health Research (SWHR) submitted a jointly-led sign-on letter commending the FDA for its ongoing commitment to the study of sex differences and encouraging consideration of the specific relevance for women at risk for or living with Alzheimer’s disease and related causes of dementia.
Unfortunately, the revised draft guidance falls short of addressing comments submitted by the LEAD Coalition and SWHR. Instead, the FDA draft guidance appears to have been revised primarily to remove gender-related terminology, with limited indication that the revisions were informed by public comments or developments in scientific literature. The LEAD Coalition and SWHR stand by comments outlined in their 2025 letter, including the importance of understanding the impact gender roles may have on the increased risk for Alzheimer’s disease and related causes of dementia and maintain that FDA must take these factors into account within the draft guidance.
The LEAD Coalition and SWHR remain eager to work together with the FDA to deepen understanding of sex differences in the clinical evaluation of medical products and to ensure that future research and resulting medical products and services are more inclusive, effective, and tailored to the needs of all individuals, including those at risk for and living with Alzheimer’s disease and related causes of dementia. LEAD and SWHR also look forward to additional comment periods to elevate this essential element of scientific rigor.