CDER Seeks Industry Feedback on Clinical Trial Innovation
Seeking to better understand innovative clinical trial designs and approaches, the FDA’s Center for Drug Evaluation and Research (CDER) has asked stakeholders to share their thoughts on the current barriers to and enablers of innovation.
“In recent years, CDER has worked to advance clinical trial innovation through numerous efforts, including public workshops, guidances, working groups and more,” the FDA said in announcing its request. “However, the incorporation of innovative clinical trial approaches in drug development programs presents some challenges that need to be further explored, along with opportunities.”
Feedback submitted to CDER will help inform future actions on trial innovation as well as an upcoming public workshop hosted jointly by FDA and the Duke-Margolis Center for Health Policy. The workshop, scheduled for March 19-20, will delve into such topics as regulatory/compliance, patient-centricity/recruitment and trial infrastructure/organizational culture.
The deadline for submitting feedback to CDER is April 19. Submit comments here.
Register for the workshop here.