Metodebevisregistrering

Adaptive Phase IV study

An Adaptive Phase IV study is a post-marketing surveillance study conducted after a drug or intervention has received regulatory approval, augmented with pre-specified adaptive design elements that allow pre-planned modifications to the study protocol in response to accumulating data. These modifications may include sample size re-estimation, endpoint adjustments, or population enrichment, all governed by statistical rules set before the study begins, preserving scientific integrity while increasing efficiency.

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Adaptive Phase IV Post-Marketing Study

Taksonomisk metoderegistrering · process-pipeline / epidemiology

Chow, S. C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman and Hall/CRC. · ISBN 978-1584889625
U.S. Food and Drug Administration. (2019). Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry. FDA. · URL

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