- August 28, 2020
- Organized By:
ABOUT THIS EVENT
The U.S Food and Drug Administration (FDA) hosteda 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 providedan introduction and discuss plans for the pilot grant program including future public meetings.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 was 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.
Grantees have developed project specific websites. As milestone documents are developed, they will be posted to these websites for stakeholder feedback.
Patient-Focused Drug Development Staff Center for Drug Evaluation and Research Office of the Center Director CDER_StandardCoreCOAs@fda.hhs.gov
|CDER Pilot Grant Program Public Meeting Agenda FINAL
|pdf (152.32 KB)
|pdf (3.19 MB)
|CDER Standard Core Sets Pilot Grant Program Public Meeting Transcript
|pdf (7.58 MB)