Challenges and regulatory experiences with non‐inferiority trial design without placebo arm

DOI10.1002/BIMJ.200800219zbMath1442.62422OpenAlexW2059291557WikidataQ83630803 ScholiaQ83630803MaRDI QIDQ5123178

H. M. James Hung, R. T. O'Neill, Sue-Jane Wang

Publication date: 25 September 2020

Published in: Biometrical Journal (Search for Journal in Brave)

Full work available at URL: https://doi.org/10.1002/bimj.200800219

zbMATH Keywords

synthesis methodnon-inferiority marginconditional type I error ratefixed margin methodunconditional type I error rate

Mathematics Subject Classification ID

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

Related Items (3)

Identification of the minimum non-inferior dose in a three-arm non-inferiority trial ⋮ Simultaneous tests of non inferiority and superiority in three-arm clinical studies with heterogeneous variance ⋮ Response-adaptive treatment allocation for non-inferiority trials with heterogeneous variances

This page was built for publication: Challenges and regulatory experiences with non‐inferiority trial design without placebo arm