FDA: Innovative Clinical Trials Are Great but Talk to Us First

The FDA took another step in encouraging drugmakers to pursue innovative ways of testing their investigational medicines, marking a shift away from what the acting head described as a “clunky” clinical trials process.

Draft guidance released Sept. 20 from the Food and Drug Administration aims to improve communication between agency reviewers and drug companies that want to use complex, innovative clinical trials for drugs and biologics. Those innovative methods include rarely used trial designs to demonstrate effectiveness.

The guidance essentially encourages early, clear interaction between the FDA and the applicant, and it details the type of documentation drug companies should ...