Today the FDA announced its plan to improve the demographics of clinical trials by including more women and minorities. The announcement was made one year after a report on clinical trial demographic findings was released. The agency found that most sponsors submitting clinical trial data have included descriptions and analyses of demographic subgroups. Although many in the industry are aware that clinical trial diversity is important, it isn’t always reflected in clinical trial enrollment and data. Clinical trials that are more inclusive provide better data and understanding of investigational products, and can improve public health in general over time.
It is crucial that trials are diverse in order to account for sex and race/ethnicity differences. Some medications and medical devices may have different responses and effects in women than men. In medical device studies specifically, women are under-represented.
The FDA’s action plan includes 27 action items and outlines three priorities:
- Improving the completeness and quality of demographic subgroup data collection
- Reporting and analysis
- Identifying barriers to subgroup enrollment in clinical trials
The last point is an important challenge to diversifying clinical trials. Organizations such as I’m In are dedicated to encouraging under-represented populations to participate in clinical trials.
You can view our currently enrolling and upcoming studies by clicking here. We also have upcoming studies that focus on women’s health issues – including bacterial vaginosis, vulvovaginal candidiasis and streptococcus B vaccine studies. You can stay updated on these and other studies by signing up for our email newsletter at the bottom right corner of our website.
