Overview
Statistical issues related to the design, conduct, and analysis of clinical trials and related biomedical studies including sample size and study length determinations, sequential procedures, and the analysis of prognostic or predictive factors in clinical trials.
Current Duke Appointments & Affiliations
Professor Emeritus of Biostatistics & Bioinformatics
·
2015 - Present
Biostatistics & Bioinformatics, Division of Biostatistics,
Biostatistics & Bioinformatics
Recent Scholarly Works
Biomarker analyses from the phase III randomized CLEAR trial: lenvatinib plus pembrolizumab versus sunitinib in advanced renal cell carcinoma.
Journal article Ann Oncol · April 2025 BACKGROUND: In CLEAR, lenvatinib + pembrolizumab (L + P) significantly improved efficacy versus sunitinib in first-line treatment of patients with advanced renal cell carcinoma (aRCC). We report results from CLEAR biomarker analyses. PATIENTS AND METHODS: ... Full text Link to item CiteAssessment of treatment effect heterogeneity for multiregional randomized clinical trials.
Journal article Stat Biopharm Res · 2025 Multiregional clinical trials (MRCTs) have become increasingly common in recent years. Detecting underlying regional heterogeneity is a critical issue for these trials. Existing methods for assessing treatment effect heterogeneity across regions have ignor ... Full text Link to item CiteRandomized phase II dose comparison LITESPARK-013 study of belzutifan in patients with advanced clear cell renal cell carcinoma.
Journal article Ann Oncol · December 2024 BACKGROUND: Belzutifan is a first-in-class hypoxia-inducible factor subunit 2α (HIF-2α) inhibitor approved at a dose of 120 mg once daily for certain adults with VHL disease and adults with advanced renal cell carcinoma (RCC) following therapy with a progr ... Full text Link to item CiteRecent Grants
Duke CTSA (TL1) Year 5
Inst. Training Prgm or CMEMentor · Awarded by National Institutes of Health · 2018 - 2024Translational meta-analysis for elderly lung cancer patients
ResearchCollaborator · Awarded by National Institutes of Health · 2013 - 2016CTSA UL
ResearchDirector · Awarded by National Institutes of Health · 2006 - 2012View All Grants
Education
Southern Methodist University ·
1969
Ph.D.