The US FDA’s formal guidance on development of COVID-19 treatments and preventative agents takes a broadly flexible approach to Phase 2 and 3 trial design, repeatedly indicating a willingness to consider varied options while urging sponsors to discuss their trials plans with the agency earlier rather than later. “FDA is committed to supporting all scientifically … Continue reading “FDA Welcomes Variety of Phase 2/3 Trial Designs for COVID-19 Therapies”
Author: Bridget Silverman
Neurology at Forefront of FDA’s Complex Innovative Trial Design Pilot
The coronavirus pandemic has frozen many clinical trials and forced others to adapt in the face of overwhelmed healthcare systems around the world. When activity resumes, trials could look different, with more remote monitoring and decentralized enrollment. They could reflect some of the design evolutions that the US Food and Drug Administration and sponsors have … Continue reading “Neurology at Forefront of FDA’s Complex Innovative Trial Design Pilot”