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Sample size determination for adaptive crossover trial in detecting gene-drug interactions
1Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois Chicago, Chicago, IL, USA.
Statistical Methods in Medical Research
|July 11, 2023
Summary
We developed a new method to calculate sample size for adaptive crossover trials, enhancing statistical power in drug-gene interaction studies. This approach ensures robust findings for treatments like those for atrial fibrillation.
Area of Science:
- Pharmacogenomics
- Clinical Trial Design
- Biostatistics
Background:
- Parallel and crossover designs are common for drug-gene interaction studies.
- Adaptive crossover designs offer patient choice but complicate sample size calculations.
- Ethical considerations and statistical power are key factors in trial design.
Purpose of the Study:
- To propose a method for determining sample size in adaptive crossover trials.
- To provide a closed-form formula for accurate sample size calculation.
- To apply the method to gene-drug interaction studies for atrial fibrillation.
Main Methods:
- Development of a closed-form formula for sample size determination.
- Application of the method to an adaptive crossover trial scenario.
- Simulation studies to confirm the statistical power of the proposed approach.
Main Results:
- A novel method for calculating required sample size was successfully developed.
- The proposed approach achieves the pre-specified statistical power in simulations.
- The method is applicable to adaptive crossover trials for gene-drug interactions.
Conclusions:
- The proposed closed-form formula effectively determines sample size for adaptive crossover trials.
- This method enhances statistical power and addresses complexities in patient-choice designs.
- Practical guidelines are provided for adaptive crossover trials, particularly for atrial fibrillation treatment.
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