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Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance

 
• By Bridget Silverman

Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.

Pulling-together
Guidance revision urges sponsors to use “an anchor-based approach, typically using Phase II trial data, to estimate clinically meaningful change” when defining endpoints.

The US Food and Drug Administration’s growing interest in core clinical outcome assessments is reflected in a revision of a 2015 draft guidance on developing drugs for gastroparesis.

The new draft guidance makes changes to the 2015 document to “reflect FDA’s current thinking about developing clinical outcome assessment tools and statistical considerations for using those tools to assess...

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