As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Einstein College of Medicine, Duke University and Northwestern University.
The grants, which total about $4 million, are meant to help collect patient input to inform the selection of clinical outcomes and how data is collected.
“If methodologically sound data collection tools are developed and used within clinical trials of an investigational therapy, patient input can provide a direct source of evidence regarding the benefits and risks of a drug,”
As far as what the grants will be used for, the $1.29 million grant to Einstein and Vector Psychometric Group will be used to develop and standardize a set of endpoints and related COAs for migraine clinical trials, with the goal of addressing symptoms “that are most important to patients suffering from migraines.”
The $1.4 million Duke grant will be used to identify COAs and endpoints for use when developing acute pain therapeutics in infants and young children under the age of two. The team will engage with patients, caregivers and clinicians to identify meaningful outcomes for acute pain clinical trials, FDA said.
“The recommended core set of COAs will be administered together in a longitudinal study among a diverse sample of children with acute pain from a range of conditions to evaluate the COAs performance,”
the Duke researchers said.
“With oversight and input from a diverse and well-rounded external technical advisory committee, completion of these goals will help ease the burden of investment in pediatric drug development and facilitate patient-centered opioid-sparing trials during the critical period of childhood.”
And the $1.4 million grant to Northwestern will seek to develop and validate COAs across various chronic conditions that assess physical function severity. “The investigators expect their work to result in core physical function outcome sets that measure the full range of physical function severity with potential generalizability across conditions,” FDA said.
The COAs will assess PF as a patient-reported outcome and a performance outcome, the researchers said. To validate COAs for conditions with mildly impaired PF, the researchers propose irritable bowel syndrome as a model. For conditions with moderately/severely impaired PF, they propose sarcopenia as a model.