Recent Regulatory Efforts on Complex Innovative Clinical Trial Designs

On-Demand Content Preview Webinar

In this webinar...

This talk will give an overview of recent FDA efforts in the area of Complex Innovative Clinical Trial Designs (CID). Topics covered will include FDA's final guidance on Adaptive Design Clinical Trials for Drugs and Biologics, FDA's draft guidance on Interacting with FDA on Complex Innovative Trial Designs, and the FDA pilot review program for CID.

This discussion will serve as a preview for the upcoming DIA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients conference on March 2-3.

Learning Objectives:

  • Identify key FDA guidance efforts in the area of complex innovative clinical trial design

Featured Topics:

  • FDA's final guidance on Adaptive Design Clinical Trials for Drugs and Biologics
  • FDA's draft guidance on Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biologics
  • FDA's pilot review program for Complex Innovative Trial Designs

Presenter:


  John Scott, PhD, Director, Division of Biostatistics, CBER, FDA