Bringing Clinical Research to Patients

Description: Recruiting and retaining diverse populations in clinical research is critically important. The FDA's Office of Women's Health works to promote the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials.

Although FDA has seen improvements in the representation of women in clinical trials submitted in FDA marketing applications over the years, representation gaps remain and there are opportunities to improve representation.

This enduring material discusses a number of novel strategies currently available for bringing clinical research to all patients, including women. Decentralized clinical trials (DCT) are trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. DCTs can apply several strategies to bring the trial to the trial participant, including through the use of video and telemedicine visits, digital health technologies, direct distribution of investigational products to participants, electronic informed consent, home visits, and local health care providers and local health care facilities. DCTs may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or access to traditional trial sites. These strategies may help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse study participant population.

Clinical research may also involve the use of real-world evidence acquired directly from health care providers or patients themselves. Further, this webinar discusses the mobile app and website called CURE ID, which FDA developed to crowdsource clinical information from health care providers and patients, including during pregnancy.