Fluff Or Next Potential Discovery? FDA Wants Simpler Clinical Trials, But Not Telling Sponsors Endpoints Are Unnecessary

Some of the growing number of secondary and tertiary endpoints may not be needed, but also could fuel future products and advance science.

simplicity — Can the FDA encourage simpler clinical trials without squelching scientific research? • Source: Shutterstock

Podium policy on clinical trial simplification does not seem to be filtering down to the US Food and Drug Administration’s rank-and-file reviewing and approving the protocols.

So-called “fluff,” or unnecessary endpoints, continues to grow, making clinical trials much more complex and burdensome, agency officials said during...