Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot

Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

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 been exploring...