Ready Or Not: FDA Accepting Adaptive Trial Applications
Executive Summary
One of the biggest adaptive trial issues yet to be hammered out between FDA and industry is who will have access to unblinded clinical trial data and what that structure would look like, according to FDA officials
You may also be interested in...
Late-Stage Trials Pose Challenge As FDA Molds Adaptive Design Guidance
The work group developing FDA's guidance on adaptive clinical trial design is still trying to figure out the complex issues associated with late-stage studies, the Center for Drug Evaluation and Research's "town hall" discussion at the Drug Information Association annual meeting in Atlanta revealed
Late-Stage Trials Pose Challenge As FDA Molds Adaptive Design Guidance
The work group developing FDA's guidance on adaptive clinical trial design is still trying to figure out the complex issues associated with late-stage studies, the Center for Drug Evaluation and Research's "town hall" discussion at the Drug Information Association annual meeting in Atlanta revealed
Industry Encouraged To Spread Its Wings In Learn Phase of Adaptive Trials
While FDA is granting industry a great deal of leeway in designing early, learn-phase adaptive trial models, the agency is suggesting that emphasis be placed on dose response and exposure risk, FDA officials indicated at a recent Pharmaceutical Research & Manufacturers of America workshop