Applies FDA's 7-step AI credibility guidance to prognostic covariate models for reducing sample sizes in registrational trials, illustrated with an Alzheimer's disease example.
Prognostic Covariate Adjustment for Logistic Regression in Randomized Controlled Trials
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Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies
Applies FDA's 7-step AI credibility guidance to prognostic covariate models for reducing sample sizes in registrational trials, illustrated with an Alzheimer's disease example.