Overview
My research interest includes statistical methodology development and application in the area of biopharmaceutical/clinical statistics such as bioavailability and bioequivalence, clinical trials, bridging studies, medical devices, and translational research/medicine. Most recently, I am interested in statistical methodology development for the use of adaptive design methods in clinical trials and methodology development for assessment of biosimilarity of follow-on biologics. In addition, I am also interested in methodology development for statistical evaluation of traditional Chinese medicine (TCM) clinical trials.
Current Duke Appointments & Affiliations
Professor of Biostatistics & Bioinformatics
·
2022 - Present
Biostatistics & Bioinformatics, Division of Biostatistics,
Biostatistics & Bioinformatics
Recent Scholarly Works
A Proposal for the Use of an Innovative Two-Stage PK-Clinical Adaptive Trial in Biosimilar Product Development
Journal article AAPS Journal · November 1, 2026 For approval of biosimilar drug products, the United States Food and Drug Administration (FDA) recommends a stepwise approach for obtaining the totality-of-the evidence for demonstration of the biosimilarity between a proposed biosimilar product and its re ... Full text CiteInternal Validity-Gated Dual Weighting: Toward Target Validity in the Synthesis of Randomized Controlled Trials and Real-World Studies.
Journal article J Evid Based Med · September 2026 AIM: Integrating randomized controlled trials (RCTs) and real-world studies (RWS) requires balancing internal and external validity to achieve target validity. We extended external validity assessment to better capture contextual complexity and diversity, ... Full text Link to item CitePower Calculation for Non-inferiority Test Based on Linear Combination of Two Correlated Binary Endpoints.
Journal article Ther Innov Regul Sci · July 2026 In cancer research, multiple primary study endpoints, which may be correlated, are often considered. In practice, it is common to evaluate each clinical endpoint separately when performing sample size calculations. However, when the endpoints are correlate ... Full text Link to item CiteRecent Grants
Tailored mHealth Coaching and Social Resource Support to Reduce Health Disparities in Kidney Transplantation
ResearchCo Investigator · Awarded by National Institutes of Health · 2026 - 2031Towards ML-Powered, Efficient and Robust Inference of Average and Individual Treatment Effects for Novel Clinical Trials in Rare Diseases
ResearchCo Investigator · Awarded by Food and Drug Administration · 2026 - 2030Targeting the B Cell Response to Treat Antibody-Mediated Rejection
ResearchStatistical Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2021 - 2028View All Grants
Education
University of Wisconsin, Madison ·
1985
Ph.D.