A Group Sequential Approach to Evaluation of Bridging Studies

DOI10.1081/BIP-120024210MaRDI QIDQ4430353zbMATH OpenOpenAlexWikidataFDO

Authors Chin-Fu Hsiao, Jia-Zhen Xu, Jenpei Liu

Publication date 7 October 2003

Published in Journal of Biopharmaceutical Statistics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1081/bip-120024210

Mathematics Subject Classification ID

Sequential statistical design (62L05) Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• Design and analysis of bridging studies with prior probabilities on the null and alternative hypotheses
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Cites work

• Discrete Sequential Boundaries for Clinical Trials
• Nonparametric Estimation of a Delay Distribution Based on Left‐Censored and Right‐Truncated Data

Cited in

(4)

• A design for survival studies: A multi-regional trial with unrecognized heterogeneity
• A Statistical Framework for Quantile Equivalence Clinical Trials with Application to Pharmacokinetic Studies that Bridge from HIV‐Infected Adults to Children
• Approaches to allocate sample size rationally into individual regions for a multi-regional trial under heterogeneous effect size
• Sample size requirements for evaluation of bridging evidence

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