FDA Grantees to Share Work on New Standard COAs and Endpoints at Public Meeting
Three clinical research groups funded by the FDA will present their work on clinical outcome assessments (COA) and standardized endpoints at a virtual public meeting Aug. 28.
The teams of investigators representing Duke University, Northwestern University and Albert Einstein College of Medicine received grants from the agency’s Standard Core Clinical Outcome Assessments and Endpoints pilot program last September. Duke’s work focuses on acute pain therapeutics in infants and young children, and Northwestern is developing COAs and endpoints for a range of chronic conditions that assess physical function. The Einstein team, in collaboration with Vector Psychometric Group, is addressing COAs and endpoints for migraine clinical trials.
The grantees will also receive feedback from meeting attendees on which of the developed standard core COA sets and endpoints support regulatory decision-making and which ones hold the most relevancy to patients. The Standard Core COA and Endpoints pilot program was developed as part of the FDA’s Patient Focused Drug Development efforts.
The FDA also will announce plans for future grants and meetings at the virtual event. The deadline for applying for grants in 2020 is Oct. 14. The 2020 grants will focus on volume or fluid overload (hypervolemia) and related impacts, age-appropriate domains of pediatric daily function, the mechanics of swallowing and motor production of speech, and systemic sclerosis.
To register for the virtual public meeting, click here: https://bit.ly/31udWbj.
For information on the pilot program and applying for 2020 grants, click here: https://bit.ly/30BiMUP.