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Trials In Focus: FDA Guidance Aims To Tackle Challenges In Multi-Endpoint Trials

Guidance Targets ‘Multiplicity Problem’

 
• By Alaric DeArment

Beam Therapeutics also announced that it dosed the first patient in its Phase I/II sickle cell disease trial; Vyne stepped into the increasingly competitive vitiligo space, while Tracon moved further into sarcomas in its checkpoint inhibitor program, and Telix started a small trial of its drug in brain cancer.  

• 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More than five years after releasing its draft guidance on clinical trials with multiple endpoints, the US Food and Drug Administration has put out a final version of that guidance, with an eye toward ensuring that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 in January 2017. (Also see "Multiple Endpoints In Clinical Trials: US FDA Advises How To Avoid False Positives" - Pink Sheet, 14 January, 2017.) The main concern is clinical trials with multiple endpoints but lack adjustment for multiplicity, leading to false conclusions about a drug’s effectiveness

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