US FDA Offers Sponsors More Attention For Sharing Complex Innovative Trial Designs

Pilot program will select two trial designs per quarter, but sponsors want to know how much information they must disclose.

Render illustration of Clinical Trial title on medical documents

The US FDA is launching a pilot program to encourage sponsors to develop innovative clinical trial designs and dispel the perception that the agency will not accept novel protocols.

FDA officials gave a preview of the program, which has yet to be announced in the Federal Register, at a March 20 public workshop on promoting the use of complex innovative designs in clinical trials of drugs and biological products

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