Multiple Endpoints In Clinical Trials: US FDA Advises How To Avoid False Positives
Draft guidance suggests ways to control for erroneous conclusions when there are multiple analyses of a drug’s effects.
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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.
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.
EU research-based industry association EFPIA has made several suggestions to improve the European Medicines Agency’s draft guideline on addressing multiplicity issues in clinical trials. Multiplicity can have a substantial influence on the rate of false-positive conclusions, which may affect approval and labeling of an investigational drug.