Power and sample size calculation for non-inferiority trials with treatment switching in intention-to-treat analysis comparing RMSTs
2024
Calculating Sample Size for Non-Inferiority Trials with Treatment Switching
publication
Author Information
Author(s): Shih Austin, Hsu Chih-Yuan, Shyr Yu
Hypothesis
How does treatment switching affect power and sample size in non-inferiority trials?
Conclusion
The proposed simulation-based approach helps understand how treatment switching influences power and sample sizes in non-inferiority trials.
Supporting Evidence
- The simulation study shows that switching time and probability can significantly affect power and sample size.
- A shorter switching time and higher switching probability amplify changes in power and sample size.
Takeaway
This study shows that switching treatments can change how many people you need in a trial and how likely it is to find a difference between treatments.
Methodology
A simulation-based approach named nifts was proposed to calculate powers and determine necessary sample sizes for non-inferiority trials with treatment switching.
Digital Object Identifier (DOI)
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