Clarkston Shares Guest Column on Sex Differences in Clinical Evaluation of Medical Products
January 29, 2025 | Liz Johnson, senior manager at Clarkston Consulting, recently shared a guest column with Clinical Leader about the sex differences in the clinical evaluation of medical products. Read an excerpt of the piece below and the full article here.
FDA Issues Draft Guidance: Study Of Sex Differences In The Clinical Evaluation Of Medical Products
The U.S. FDA recently released a draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products,1 which deduced that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials for drugs and medical devices as well as some therapeutic areas. This often occurs where the disease or condition affects both males and females, making it challenging to evaluate the benefits and risks of medical products for females, including dosing requirements. The FDA published updated guidance to provide insight on:
- increasing enrollment of females in clinical trials and non-interventional studies to help ensure the generalizability of results
- analyzing and interpreting sex-specific data
- including sex-specific information in regulatory submissions of medical products.