Sex Differences in Clinical Evaluations of Products

FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for increasing the number of females in clinical trials and non-interventional studies to help ensure the generalizability of results. The document says it also has recommendations for analyzing and interpreting sex-specific data and including sex-specific information in regulatory submissions of medical products.

Historically, the agency notes, fewer females than males have been included in clinical trials of medical products, which has led to a lack of information available for females and their healthcare providers about the benefits and risks of such medical products in females.

When finalized, the guidance will replace a 7/1991 guidance.

The document contains an Introduction, Background, Clinical Trial Design and Conduct, Statistical Concepts, Nonclinical Considerations, Other General Considerations, and References.