I ran across an interesting article in “The Gray Sheet” on strategies to increase the enrollment
of women in clinical trials. The FDA notes that adequate and appropriate populations of women are needed to support 510(k) clearances and PMAs.
In its “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” guidance released (covered in a recent blog) on August 22nd, the FDA provides 10 recommendations product sponsors can use to increase recruitment of women into their ongoing clinical trails:\
- Target investigation sites, such as women’s clinics, where recruitment of women is more straightforward.
- Consider alternative communication strategies – such as those used in the 2003 – published Women’s Health Initiative Study – for study recruitment.
- If women are likely to benefit from a device, but may not meet enrollment criteria, consider revising the criteria.
- Responsibly enroll women of child-bearing age with appropriate risk reduction to avoid pregnancy during the clinical trial.
- Include provisions to reach target enrollment for women, such as maintaining open enrollment for them until the pre-specified proportion attained.
- Investigate reasons for under-enrollment of women, or other key demographic groups.
- Plan focused effort to enroll women under a continued access study, as laid out in the CDRH “Guidance on IDE Policies and Procedures.”
- Consider factors to increase recruitment and retention, such as involving local physicians, or providing incentives for compensation, such as transportation costs.
- Consider flexibility in follow-up visit scheduling and provisions of child care or elderly care services during appointments; or allow evening or weekend appointments.
- For in vitro diagnostic tests and diagnostic services, include samples from both women and men at the cutoff selection validation stages.
Much like the draft version of the sex specific data guidance released in December 2011 the final guidance emphasizes the type of analyses that the agency will expect from companies to make the most out of sex-specific data that is collected.
Do you have any additional ideas that can help increase recruitment of women in clinical trials? What are some of the hurdles you face in recruiting women? Please share your thoughts below.
Photo Credit: Andrew Lewin
