20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials to minimise 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 favourably affect one or more disease characteristics. As the number of endpoints analysed 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.

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