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 been exploring as part of the complex innovative trial design pilot—and will be put to the test during the development COVID-19 vaccines and therapeutics.