Sample size recalculation in multicenter randomized controlled clinical trials based on noncomparative data

• Published in: Biometrical journal Vol. 62; no. 5; pp. 1284 - 1299
• Main Authors: Harden, Markus, Friede, Tim
• Format: Journal Article
• Language: English
• Published: Germany Wiley - VCH Verlag GmbH & Co. KGaA 01.09.2020
• Subjects: adaptive design; Clinical trials; Computer simulation; Diabetes mellitus; Evaluation; Heterogeneity; hierarchical model; internal pilot study; linear mixed model; Monte Carlo simulation; Nuisance; Parameter estimation; Quadratic forms; Risk reduction; Size determination; Statistical analysis; Structural hierarchy; internal pilot study; hierarchical model; linear mixed model; adaptive design

Many late‐phase clinical trials recruit subjects at multiple study sites. This introduces a hierarchical structure into the data that can result in a power‐loss compared to a more homogeneous single‐center trial. Building on a recently proposed approach to sample size determination, we suggest a sam...