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  4. ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients - 09/06/2024
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Event Title
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
September 6, 2024

Date:
September 6, 2024
Time:
9:00 a.m. - 5:00 p.m. ET

Workshop Location

FDA White Oak Campus
Building 31, Conference Center, The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993

Organized by: CDER’s Office of New Drugs

Summary

FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI) is convening this one-day workshop to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate and other topics.

Goals and Objectives

  • Clinical trial populations should, in general, align with the population affected by the disease.
  • Some populations are frequently underrepresented in clinical trials despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population. Studies that do not include individuals from underrepresented populations can perpetuate and exacerbate gaps in access, gaps in knowledge, and disparities in health outcomes.
  • Adequate representation of these populations in clinical trials helps ensure that the data generated in the development program reflect the diversity of the population expected to use the drug or biological product, if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with or occur more frequently within these populations.

Workshop Agenda

To view agenda, please use this link: ADEPT 9 Workshop Agenda.

Topics for Discussion

  • Challenges of pediatric clinic trial participation
  • Understand metrics for assessing diverse clinical study enrollment, including considerations of disease prevalence and incidence across subgroups of the pediatric population.
  • Discuss key elements of a strategy to include underrepresented populations, including trial design and methodological considerations, community engagement, recruitment and retention practices, and other related topics.

Attendance Information

All interested in attending are encouraged to register early.

This workshop will be held in-person on the FDA White Oak campus and in a virtual format via Zoom. Registration is required to attend. Workshop will be available for virtual viewing via Zoom on the day of the meeting. All information will be sent to attendees prior to the workshop. If you are unable to download Zoom, you can also use the browser version of Zoom for viewing this workshop.

Registration

Registration is free. All interested parties are encouraged to register early. This workshop will be held in-person and in a virtual format via Zoom. Registration is required for both in-person and virtual attendance. To attend, please register online for the workshop.

  • Online registration for in-person attendance will remain open until 8:30 a.m. Eastern Standard Time on Friday, September 6, 2024. Registrants will receive an email confirmation after they register. In-person, on-site registration will continue throughout the day.
  • Registration for virtual attendance will be available until 5:00 p.m. Eastern Standard Time on Friday, September 6, 2024. To add a calendar notification to your personal calendar you may select one of these links: Add to Google Calendar or Add to Outlook Calendar. Campus visitor information will be sent to in-person attendees prior to the workshop.

Special Accommodations

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before to the workshop. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Visiting the FDA Campus

Entrance for public workshop attendees (non-FDA employees) is through Building 1. All attendees (FDA and non-FDA) attending the workshop in-person will be required to pass through routine security check procedures like TSA screening at airports. Laptops, tablets, cell phones, keys, car fobs, coins and other metal items must be removed from pockets and put in a bin or tray. Hats will need to be removed. Outer coats, belts, shoes, watches, or other jewelry do not have to be removed. After passing through security screening, attendees will be directed to the workshop room in Building 31.

For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Contact

For additional details, contact the FDAs CDER/OND/Public Meeting Team at ONDPublicMTGSupport@fda.hhs.gov.

Event Materials

Title File Type/Size
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients - Transcript pdf (5.82 MB)
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients - Speaker Presentations and Recordings
*Scroll down to “Workshop Details”, click on the plus sign (+) to expand the section to view the session recordings and speaker slide decks. 		n/a
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