Blinded sample size reestimation in non-inferiority trials with binary endpoints

DOI10.1002/BIMJ.200610373zbMATH Open1442.62365OpenAlexW2102434880WikidataQ47272696 ScholiaQ47272696MaRDI QIDQ5122986FDOQ5122986

Authors: Tim Friede, Charles Mitchell, Günther Müller-Velten 

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.200610373

Recommendations

• Sample size calculation and blinded sample size recalculation in clinical trials where the treatment effect is measured by the relative risk
• Including long- and short-term data in blinded sample size recalculation for binary endpoints
• Robustness of sample size re-estimation with interim binary data for double-blind clinical trials
• Blinded sample size re-estimation in clinical trials comparing several treatments
• Blinded sample size recalculation for normally distributed outcomes using long- and short-term data

zbMATH Keywords

clinical trialsnuisance parameterinternal pilot studysample size reestimationnon-inferiority study

Mathematics Subject Classification ID

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

Cited In (11)

• Including long- and short-term data in blinded sample size recalculation for binary endpoints
• Corrigendum to: Robustness of sample size re-estimation with interim binary data for double-blind clinical trials.
• Robustness of sample size re-estimation with interim binary data for double-blind clinical trials
• Estimation of Treatment Difference and Standard Deviation with Blinded Data in Clinical Trials
• Sample size calculation and blinded sample size recalculation in clinical trials where the treatment effect is measured by the relative risk
• Sample size re-estimation: nonparametric approach
• Blinded sample size re-estimation in clinical trials comparing several treatments
• Score confidence intervals and sample sizes for stratified comparisons of binomial proportions
• Sample size determination and re-estimation for matched pair designs with multiple binary endpoints
• Blinded sample size re-estimation with unequal variances and center effects in clinical trials
• Blinded versus unblinded estimation of a correlation coefficient to inform interim design adaptations

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