The U.S. Food and Drug Administration is scheduled to host a public workshop on Oct. 15-16 to discuss what is important to patients and caregivers and clinical outcomes assessments (COAs).
According to an announcement from the FDA, the workshop will focus on:
- Methodological approaches that may be used to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease; and
- The best practices for selecting, developing or modifying fit-for-purpose clinical outcome assessments to measure patient experience in clinical trials.
The workshop is slated for 9 a.m. – 5 p.m. EST at the FDA White Oak Campus in Maryland.