Drugmaker Guidance Available on Changing Clinical Trials Midway

Drugmakers will be better able to hone their tests of medicines under development with new FDA guidance that tells them how to adapt their clinical trials midway through.

The Food and Drug Administration’s final guidance on adaptive clinical trials, announced Nov. 29, provides recommendations on the appropriate use of clinical trial designs that might evolve as data is collected.

The FDA proposed the guidance in October 2018 as a way of speeding effective drugs and biologics to market.

“Adaptive clinical trials can give sponsors the flexibility to react to clinical evidence as it’s being collected, and modify the design and ...