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.
Restricted mean survival time estimation using covariate adjusted pseudovalue regression to improve precision
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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.