The Fact
A U.S. Government Accountability Office review reported that in July 2001 the FDA did not know how many women were included in clinical trials for new drugs, despite regulations requiring safety and efficacy data to be presented separately for men and women. GAO’s own analysis found women were sufficiently represented overall, but FDA lacked a management system to record and track participation or monitor compliance.
What This Means
Putting women into trials was only part of the job. The regulator also needed to know they were there and examine whether drugs worked differently or caused different harms in women.
A clinical trial can include women and still miss a sex difference if the data are not tracked and analyzed that way.
Sources
- U.S. General Accounting Office. Women’s Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement. GAO-01-754. July 6, 2001. https://www.gao.gov/products/gao-01-754