9 Statistics on Male, Female Participation in FDA Clinical Trials

The sex ratio in post-approval studies mandated by the U.S. Food and Drug Administration varies greatly in certain clinical areas, even reaching an imbalance of nine females to every one male, according to a study published in the Journal of Women's Health.

Researchers analyzed 89 studies where sex of the participant was included in the report.

Of those 89 studies, 29 (33 percent) had 50 percent or more female participants, 60 (67 percent) had less than 50 percent female participants and 15 (17 percent) enrolled less than 25 percent female participants.

Here are the inclusion rates of women versus men in post-approval studies for medical devices in certain clinical areas.

•    Cardiovascular: 32 percent female, 68 percent male
•    Orthopedic: 43 percent female, 57 percent male
•    Neurologic: 43 percent female, 57 percent male
•    Ear, nose and throat: 48 percent female, 48 percent male
•    Renal and urologic: 41 percent female, 59 percent male
•    Diagnostic and general hospital: 54 percent female, 46 percent male
•    Ophthalmic: 63 percent female, 37 percent male
•    Plastic and reconstructive: 90 percent female, 10 percent male
•    Dental: 92 percent female, 8 percent male

Researchers noted some of the disparities may be due to certain conditions being more prevalent in either women or men. For example, women tend to have higher rates of temporomandibular joint and muscle disorder, dysfunction in the joints and muscles of the jaw, which may explain the high rates of female presence in dental studies.

Researchers suggest the FDA continues to carry out studies that ensure percentages of male and female participants are "consistent with the sex-specific prevalence for the disease or condition the device is used to treat," according to the study.

More Articles on Clinical Trials:

FDA Drug Approval Processes Not Consistent
FDA Approves Medtronic's CoreValve Transcatheter Without Panel Review
U.S. Biomedical Research is Slipping — What it Means for U.S. Innovation

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