Scholars@Duke
Shein-Chung Chow

Shein-Chung Chow

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
sheinchung.chow@duke.edu
Duke Box 2721, Durham, NC 27710
2424 Erwin Road Ste 1102, 11037 Hock Plaza, Durham, NC 27705

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 Appointments & Affiliations

Professor of Biostatistics & Bioinformatics · 2022 - Present Biostatistics & Bioinformatics, Division of Biostatistics, Biostatistics & Bioinformatics

Recent Publications

A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials.

Journal Article Ther Innov Regul Sci · May 2025 In clinical development, an independent data safety monitoring committee (IDMC) is often established to ensure the test treatment's integrity, quality, safety, and efficacy under investigation. In clinical trials, IDMC may recommend stopping the trial earl ... Full text Link to item Cite

Application of complete N-of-1 trial design in bioequivalence-biosimilar drug development.

Journal Article J Biopharm Stat · April 29, 2025 Biosimilars play a crucial role in increasing the accessibility and affordability of biological therapies; thus, precise and reliable assessment methods are essential for their regulatory approval and clinical adoption. Currently, the 2-sequence 2-period c ... Full text Link to item Cite

Alcohol Relapse After Liver Transplantation: Risk Factors, Outcomes, and a Comparison of Risk Stratification Models.

Journal Article Gastro Hep Adv · 2025 BACKGROUND AND AIMS: Alcohol-related liver disease is a leading cause of liver transplantation (LT) in the United States; however, alcohol relapse remains a risk, and real-world assessment of relapse prediction scores is lacking. The primary aim of this st ... Full text Link to item Cite
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Recent Grants

Targeting the B Cell Response to Treat Antibody-Mediated Rejection

ResearchStatistical Investigator · Awarded by National Institutes of Health · 2021 - 2028

Red blood cell ATP export and transfusion in sepsis (R01)

ResearchBiostatistician · Awarded by National Heart, Lung, and Blood Institute · 2023 - 2026

Methods to improve efficiency and robustness of clinical trials using information from real-world data with hidden bias

ResearchCo Investigator · Awarded by Food and Drug Administration · 2023 - 2026

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Education, Training & Certifications

University of Wisconsin, Madison · 1985 Ph.D.