- December 5, 2019
- 8:30 AM - 12:00 PM ET
Event LocationWhite Oak Campus: The Great Room
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
- Organized By:
Comment period extended to March 6, 2020.
The U.S Food and Drug Administration (FDA) is hosting a public meeting to provide an opportunity for grantees funded as part of the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program to share their development plans for the standard core COA sets and to receive feedback from stakeholders. FDA will provide an introduction and discuss plans for the pilot grant program including future public meetings.
As part of our Patient Focused Drug Development (PFDD) efforts, the FDA developed a pilot grant program to support the development of publicly available standard core set(s) of COAs and their related endpoints for specific disease indications. On September 11, 2019 the FDA made three awards under this grant program in the areas of: (1) migraine, (2) acute pain in infants and young children, and (3) physical function across a range of chronic conditions.
The purpose of this public meeting is to ensure that, as these standard core sets of clinical outcome assessments are developed, the identified concepts, COAs, and endpoints reflect what is most important and relevant to patients and support regulatory and potentially other stakeholder decision making.
A standard core set of COAs can include different types of COAs such as patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) instruments and their related endpoints. These sets should assess a minimum list of impacts that matter most to patients, are likely to demonstrate change (including differences in trial arms related to disease burden, treatment burden, and if applicable, physical function), and should be assessed during a clinical trial. A standard core set might be relevant across several disease populations or subgroups or be focused on attributes of a specific disease.
REGISTRATION AND CHECK-IN
Persons interested in attending this public meeting in person or via webcast must register online at https://standard_core_coa_grant_program.eventbrite.com by December 2, 2019 at 11:59 p.m. Eastern Time. Registration is free and based on space availability, with priority given to early registrants. Early registration for in person attendance is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8:00 a.m.
If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. Registration for online attendance via webcast will remain open throughout the day of the meeting.
If you need special accommodations due to a disability, please contact Meena Savani at (240) 402-1348 or CDER_StandardCoreCOAs@fda.hhs.gov no later than November 25, 2019.
- Public Meeting Agenda (PDF - 110 KB)
This public meeting will also be webcast. Webcast information will be provided upon completion of registration. If you have not used Connect Pro before, test your connection at Meeting Connection Diagnostic. To get a quick overview of the Connect Pro program, visit Adobe Connect Pro Overview.
In addition to providing input at the public workshop, stakeholders are invited to submit comments through the public docket. The public docket comment period has been extended to March 6, 2020.
Entrance for the public meeting participants (non-FDA employees) is through Building 1. Please allow time for routine security checks, as screening procedures will be performed. For parking and security information, please refer to the following link: Public Meetings at the FDA White Oak Campus.
Patient-Focused Drug Development Staff Center for Drug Evaluation and Research Office of the Center Director CDER_StandardCoreCOAs@fda.hhs.gov
- Federal Register Notice
- Meeting Transcript (6.33 MB)
- Meeting Recordings
|Standard Core Sets COA Grant Program Public Meeting Transcript||pdf (6.33 MB)|