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 enrollment in trials by including more patients with characteristics that help predict that they’re more likely to derive a benefit,” then-FDA Commissioner Scott Gottlieb said at the time.

For example, clinical trial runners can exclude patients with characteristics that suggest that they’re more likely to suffer a side effect. That can give the FDA and drugmakers more information about patient characteristics that can inform safer prescribing.

The FDA is collecting comments on the final guidance for 30 days.