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Overview

FDA’s Office of Women’s Health (OWH), in collaboration with the Center for Drug Evaluation and Research (CDER) Office of Medical Policy (OMP), will host a free public webinar to discuss the new strategies currently available for bringing clinical research to all patients, including women.  

About DCTs

Decentralized clinical trials (DCT) are trials where some or all 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 using 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 (RWE) acquired directly from health care providers or patients themselves. Further, this webinar will discuss the mobile app and website CURE ID, which FDA developed to crowdsource clinical information from health care providers and patients, including during pregnancy.

Additional information about attending

The webinar will be held virtually on the Zoom platform and registrants will receive a link to attend after completing their registration. Live closed captioning will be available during the webinar. If you require additional accommodations, please request them when completing your registration. 

A video recording of this webinar will be available on the OWH website a few weeks after the event ends.  

For questions about this event please email OWHmeetings@fda.hhs.gov.

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