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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Bringing Clinical Research to Patients

Step Status
Educational Content
Starts On: Thu, 1/25/24: 12:00 AM EST
Ends On: Sun, 1/24/27: 12:00 AM EST
Type: Enduring Material
Credits: 1
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.
  • Discuss the use of mobile technology and crowdsourcing clinical information from patients and providers.
  • Describe the types of strategies used in decentralized clinical trials (DCTs) to bring clinical trials to study participants.
  • Summarize the roles and responsibilities of sponsors and investigators in DCTs.
Additional Information: Review the Activity Announcement for additional details: Announcement Form