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.
Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study
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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.