Blinded sample size re-estimation with unequal variances and center effects in clinical trials

DOI10.1080/03610929808832102MaRDI QIDQ4386003zbMATH OpenOpenAlexWikidataFDO

Authors Weichung Joseph Shih, Jianmin Long

Publication date 25 May 1998

Published in Communications in Statistics: Theory and Methods (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1080/03610929808832102

zbMATH Keywords

interim analysismixture of normal distributionsunequal variancesmulti-center clinical trials

Mathematics Subject Classification ID

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

Recommendations

• Blinded sample size re-estimation in clinical trials comparing several treatments
• Blinded sample size reestimation in non-inferiority trials with binary endpoints
• Blinded and unblinded sample size reestimation procedures for stepped-wedge cluster randomized trials
• Supporting information blinded sample size recalculation in multicentre trials with normally distributed outcome
• Blinded and unblinded sample size reestimation in crossover trials balanced for period
• Sample size calculation and blinded sample size recalculation in clinical trials where the treatment effect is measured by the relative risk
• Blinded sample size recalculation for normally distributed outcomes using long- and short-term data

Cites work

• scientific article; zbMATH DE number 44961 (Why is no real title available?)
• Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance

Cited in

(8)

• Supporting information blinded sample size recalculation in multicentre trials with normally distributed outcome
• Robustness of sample size re-estimation with interim binary data for double-blind clinical trials
• Variance Estimation in Clinical Studies with Interim Sample Size Reestimation
• Estimation of Treatment Difference and Standard Deviation with Blinded Data in Clinical Trials
• Blinded and unblinded sample size reestimation procedures for stepped-wedge cluster randomized trials
• Blinded and unblinded sample size reestimation in crossover trials balanced for period
• Bayesian blinded sample size re-estimation
• Blinded sample size re-estimation in clinical trials comparing several treatments

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