Journal ArticleStat Methods Med Res · June 2025
This study addresses a critical gap in the design of clinical trials that use grouped sequential designs for one-sample or paired ordinal categorical outcomes. Single-arm experiments, such as those using the modified Rankin Scale in stroke trials, undersco ...
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Journal ArticleStat Med · March 15, 2025
Group sequential trials include interim monitoring points to potentially reach futility or efficacy decisions early. This approach to trial design can safeguard patients, provide efficacious treatments for patients early, and save money and time. Group seq ...
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Journal ArticleBiomedicines · September 26, 2024
OBJECTIVES: The design of cancer clinical trials incorporating biomarkers depends on various factors, including the trial phase, the type of biomarker and whether its role has been validated. This article aims to present a method for designing and analyzin ...
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Journal ArticleEBioMedicine · July 2024
BACKGROUND: Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with traditional endocrine therapy (ET) are now the recommended first-line treatment for hormone receptor (HR)-positive and HER2-negative metastatic breast cancer (MBC). However, th ...
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