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US FDA Guidance Aims To Tackle Challenges In Multi-Endpoint Trials

Guidance Targets ‘Multiplicity Problem’

 
• By Alaric DeArment

Final guidance targets the ‘multiplicity problem.’ At about half the length of the 2017 draft, the final removes some sections, truncates other and drops several examples.

• Source: Shutterstock

More than five years after releasing its draft guidance on clinical trials with multiple endpoints, the US Food and Drug Administration has put out a final version of that guidance, with an eye toward ensuring that in particular, studies with more than one independent primary endpoint do not run the risk of producing results with false positives or false negatives about a drug’s efficacy.

The FDA released the final guidance on 21 October, having put out a draft version of the guidance...

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