Drugs

Guide to Increase Female Enrollment in Trials

FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for (1) increasing the enrollment of females in clinical trials and non-interventional studies; (2) analyzing and interpreting sex-specific data; and (3) including sex-specific information in regulatory submissions of medical products. The document says that although there has been an increase in the representation of females in clinical trials for drugs and medical devices over recent decades, they remain underrepresented in some therapeutic areas, making it “challenging to evaluate the benefits and risks of medical products for females in these therapeutic areas.”

In areas where males may be underrepresented in clinical trials, the agency says, the general principles outlined in the guidance also apply to increasing the enrollment of males in clinical trials.

When finalized, this guidance will replace a 7/1993 guidance.

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

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome