Event
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
Friday, September 6, 2024
9:00 a.m.-5:00 p.m.
FDA White Oak Campus, Silver Spring Maryland
https://lu.ma/rv4d2d9t
This public workshop will be hosted by the FDA/CDER Office of New Drugs in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). The purpose is to solicit input from stakeholders on: 1) Increasing the enrollment of historically underrepresented population in pediatric clinical studies, and 2) Encouraging pediatric clinical study participation that reflects the prevalence of the other disease or condition among demographic subgroups, where appropriate and other topics.
Background
— 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.
Agenda
To view agenda, please use this link
Registration
Registration is free. All interested parties are encouraged to register early. To register, please use this link
This workshop will be held in-person and in a virtual format. Registration is required for both in-person and virtual attendance. Registration will be available for in-person attendance until 5:00 PM ET on Friday, August 23, 2024. Registrants will receive confirmation when they register.
On-Site Attendance
For information related to in-person attendance, please visit Public Workshop Information.
Virtual Attendance (Zoom Webinar)
This meeting 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.
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 and Security
Entrance for public workshop attendees (non-FDA employees) is through Building 1. Non-FDA attendees will be required to present a government-issued ID (e.g., passport, driver's license) before going through security.
All attendees (FDA and non-FDA) attending the workshop in-person will need to pass through routine security check procedures like TSA screening at airports. Laptops, tablets, cell phones, keys, car fobs, coins and other metal items from pockets must be 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.
Food and Beverage Options:
Coffee, beverages, light breakfast items, crafted artisan salads and sandwiches will be available for purchase at the kiosk. The kiosk is the only accessible vendor to purchase food and beverage to non-FDA employees. Please note, the kiosk closes at 2 p.m., should you need an afternoon snack or beverage.
Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $25,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
