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.
The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies
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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.