Variance Estimation in Clinical Studies with Interim Sample Size Reestimation

DOI10.1111/J.1541-0420.2005.00315.XMaRDI QIDQ5714617zbMATH OpenOpenAlexWikidataFDO

Authors Frank Miller

Publication date 3 January 2006

Published in Biometrics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1111/j.1541-0420.2005.00315.x

zbMATH Keywords

variance estimationadaptive designclinical studiesbias of variance estimationbounds for biasinterim sample size reestimation

Mathematics Subject Classification ID

Estimation in survival analysis and censored data (62N02) Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• Blinded sample size recalculation for normally distributed outcomes using long- and short-term data
• Sample size reassessment in adaptive clinical trials using a bias corrected estimate
• Blinded sample size re-estimation with unequal variances and center effects in clinical trials
• Sample size re-estimation in clinical trials
• Robustness of sample size re-estimation with interim binary data for double-blind clinical trials

Cites work

• A Two-Sample Test for a Linear Hypothesis Whose Power is Independent of the Variance
• An Improved Double Sampling Procedure Based on the Variance
• Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance

Cited in

(7)

• Robustness and corrections for sample size adaptation strategies based on effect size estimation
• scientific article; zbMATH DE number 2172880 (Why is no real title available?)
• Robustness of sample size re-estimation with interim binary data for double-blind clinical trials
• Internal pilot design for balanced repeated measures
• Blinded versus unblinded estimation of a correlation coefficient to inform interim design adaptations
• Practical Methods for Bounding Type I Error Rate with an Internal Pilot Design
• Blinded and unblinded internal pilot study designs for clinical trials with count data

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