Incorporating historical information in biosimilar trials: challenges and a hybrid Bayesian-frequentist approach

DOI10.1002/BIMJ.201700152MaRDI QIDQ4563265zbMATH OpenOpenAlexWikidataFDO

Authors Johanna Mielke, Heinz Schmidli, Byron Jones

Publication date 31 May 2018

Published in Biometrical Journal (Search for Journal in Brave)

Full work available at URL https://zenodo.org/record/1199159

zbMATH Keywords

type I error rate controlBayesian approachfrequentist approachequivalence testsbiosimilarityhumira

Mathematics Subject Classification ID

Bayesian inference (62F15) Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• Dynamic borrowing through empirical power priors that control type I error
• Robust meta‐analytic‐predictive priors in clinical trials with historical control information
• Hierarchical commensurate and power prior models for adaptive incorporation of historical information in clinical trials
• Bayesian design of biosimilars clinical programs involving multiple therapeutic indications
• Elastic priors to dynamically borrow information from historical data in clinical trials

Cited in

(5)

• Power gains by using external information in clinical trials are typically not possible when requiring strict type I error control
• Commensurate priors for incorporating historical information in clinical trials using general and generalized linear models
• Power prior for borrowing the real-world data in bioequivalence test with a parallel design
• BOB: Bayesian optimal design for biosimilar trials with co-primary endpoints
• Confidence intervals with maximal average power

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