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Activity Number:
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29
- Statistical Issues Specific to Therapeutic Areas, Power and Sample Size Calculations, and Trial Monitoring
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Type:
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Contributed
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Date/Time:
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Sunday, August 8, 2021 : 1:30 PM to 3:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318442
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Title:
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Power Analyses of Oncology Clinical Trials with Stratified Randomization
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Author(s):
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Xiao Fang* and Paul DeLucca and Fang Liu and Xuan Deng and Devan V Mehrotra
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Companies:
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Merck and Merck and Merck & Co., Inc. and Merck & Co. Inc and Merck & Co., Inc.
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Keywords:
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power analyses;
stratified randomization;
oncology;
trial design
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Abstract:
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In modern clinical trials, stratified randomization is often used to prevent imbalance between treatment groups for factor(s) assumed to influence the clinical response of interest. Participants who enter a trial are first assigned into strata according to the clinical features. Within each stratum, participants are then randomized to one of the treatment groups. In oncology trials, it is very common to have 2 or more stratification factors, which would introduce 4 or more strata. However, during the trial design phase, power calculations are usually performed based on unstratified analyses. To assess the impact on the power by the stratification factors in oncology trials, simulations with different scenarios are conducted on the time-to-event outcome. Trial designs with different numbers of stratification factors and levels within each factor, and various sample sizes and hazard ratios within each stratum are explored. Results from the stratified power analyses will be compared to the unstratified analyses.
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Authors who are presenting talks have a * after their name.
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