The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood of making false conclusions of a drug’s effects.
“Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. As the number of endpoints analyzed in a single trial increase, the likelihood of making false conclusions about a drug’s effects with respect to one or more of those endpoints becomes a concern if there is not appropriate adjustment for multiplicity,” the agency said.
The final version makes several changes, including the addition of language discussing the differences and the relationship between primary, secondary and exploratory endpoints. In addition, FDA said editorial changes were made to “improve clarity by reducing redundancies in the text.”
Commenters on the January 2017 draft had sought additional revisions to the guidance. (RELATED: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance, Regulatory Focus 16 March 2017)…
