Drugs

Public Meeting on Clinical Outcome Assessments Pilot

FDA has announced a 12/5 public meeting on its Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program. The meeting is intended to allow grantees to share their development plans for the standard core COA sets and to receive feedback from stakeholders. FDA will also provide an introduction and discuss plans for the pilot grant program including future public meetings.

The pilot grant program is part of FDA’s patient-focused drug development efforts to support the development of publicly available standard core set(s) of COAs and their related endpoints for specific disease indications, an agency notice says. Last month, the agency announced three awards under the 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,” FDA says. “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.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome