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[Sample Size Calculation using SAS for PhaseⅡin Two-stage Clinical Trials of Anti-tumor Drugs]
Ji-Jie Li1, Li-Sha Hou1, Ping Zhu1
1Department of Epidemiology and Biostatistics, West China School of Public Health, Sichuan University, Chengdu 610041, China.
Objective:
To compare Gehan two-stage design and Simon two-stage design in sample size calculations for phase Ⅱ clinical trials of anti-tumor drugs.
Methods:
We explained the sample size calculation methods with a single-stage design, Gehan two-stage design, and Simon optimal two-stage and minimax two-stage designs in line with the principle of exact binomial probability. By setting up different parameters in SAS macro program, the advantages and disadvantages of these designs were compared.
Results:
The minimax two-stage design does not increase the maximum sample size compared with the single-stage design. Compared with the Gehan two-stage design, the Simon two-stage design has the advantage of being able to determine an early termination of trials when no or low anti-tumor activities are evident.
Conclusion:
Simon two-stage design is better than single-stage design and Gehan two-stage design. The minimax design is more popular than the optimal design.
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