Power and sample size calculation for non-inferiority trials with treatment switching in intention-to-treat analysis comparing RMSTs

This simulation-based approach provides power and sample size calculation in NI trials with treatment switching, when comparing the RMSTs of two treatment groups in ITT analysis. With its comprehensive parameter settings, nifts will be useful for designing NI trials that allow for treatment switching. nifts is freely available at https://github.com/cyhsuTN/nifts .

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Publication Details

Journal
BMC Medical Research Methodology
Published
2025-06-07
DOI
https://doi.org/10.1186/s12874-025-02604-3
Citations
1
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
2.63

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article

Power and sample size calculation for non-inferiority trials with treatment switching in intention-to-treat analysis comparing RMSTs

Yu Shyr, Chih‐Hung Hsu, A. Shih
1 citations
BMC Medical Research Methodology
Statistical Methods in Clinical Trials
2.63
article

Power and sample size calculation for non-inferiority trials with treatment switching in intention-to-treat analysis comparing RMSTs

Yu Shyr, Chih‐Hung Hsu, A. Shih
article en
1 citations

Abstract

This simulation-based approach provides power and sample size calculation in NI trials with treatment switching, when comparing the RMSTs of two treatment groups in ITT analysis. With its comprehensive parameter settings, nifts will be useful for designing NI trials that allow for treatment switching. nifts is freely available at https://github.com/cyhsuTN/nifts .

BMC Medical Research MethodologyVol. 25(1)
Vanderbilt University (US)
National Institutes of Health
Peace, Justice and strong institutions
Openalex Percentile: Top 11%
Statistical Methods in Clinical Trials
2.63
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