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Selected Publications


Sequential design for paired ordinal categorical outcome.

Journal Article Stat 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 ... Full text Link to item Cite

Group Sequential Test for Two-Sample Ordinal Outcome Measures.

Journal Article Stat 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 ... Full text Link to item Cite

Randomized Phase II Cancer Clinical Trials to Validate Predictive Biomarkers.

Journal Article Biomedicines · 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 ... Full text Link to item Cite

Clinical efficacy of CDK4/6 inhibitor plus endocrine therapy in HR-positive/HER2-0 and HER2-low-positive metastatic breast cancer: a secondary analysis of PALOMA-2 and PALOMA-3 trials.

Journal Article EBioMedicine · 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 ... Full text Open Access Link to item Cite