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Registration required to attend: https://www.surveymonkey.com/r/8LVJXNQ

Twitter: #ConversationsOnCancer

Background

The FDA Oncology Center of Excellence (OCE) Conversations on Cancer public panel discussion series event on July 27, 2022, will address clinical trial site selection in the context of declining U.S. patient enrollment, geo-political turmoil, and our commitment to equity and diversity in clinical trials.

Recent trends in oncology drug development have seen a shift to more international clinical trials, as rates of US patient enrollment decline. The OCE is aware of several ongoing or completed clinical trials which are multi-regional but lack US patient enrollment. Importantly, due to travel restrictions stemming either from the global pandemic or geo-political turmoil, FDA is not able to inspect certain regions of the world in which there is significant clinical trial activity. Given recent efforts to increase access to US clinical trial sites and in turn diversity, a deeper understanding of the site selection process is warranted.

Gaining an accurate understanding of patient perceptions of clinical trial enrollment may also help inform future directions in this space. This panel discussion will feature a diverse group of speakers, including patients, clinicians, researchers, and FDA representatives to share their unique perspectives on the complex topic of site selection. The speakers will discuss their understanding of clinical trial site selection and its relevance to OCE’s ongoing efforts under Project Equity, to ensure that the data submitted to the FDA for approval of oncology products adequately reflects the demographic representation of patients for whom the medical products are intended.

Webcast Information:

A free-of-charge webcast of this public panel discussion will be provided. Registration for the webcast is required at the link above.

FDA plans to post archived webcast of this Conversations on Cancer program at: https://www.fda.gov/about-fda/oncology-center-excellence/conversations-cancer

Contact:

For any inquiries regarding this program, please send an email to: OCE-Engagement@fda.hhs.gov