Title : Practical and Challenging Statistical Issues in Regulatory Science
Professor Shein-Chung Chow, Duke University
Naitee Ting



During drug and biologic product development, some practical and challenging issues are evitably encountered. These issues have an impact on the process of regulatory review and approval. These issues include, but are not limited to, (i) the use of 90% confidence interval approach for generics/biosimilars versus the use of 95% confidence interval approach for new drugs, (ii) the selection of study endpoints, (iii) the selection of non-inferiority (similarity) margin, (iv) sample size requirement, and (v) design and analysis for rare diseases clinical trials. Most recently, United States Food and Drug Administration (FDA) has kicked off several critical clinical initiatives to not only improve but also to shorten drug and biologic product development. These clinical initiatives include big data analytics, real world data/evidence, complex innovative design (including adaptive design and n-of-1 trial design), model-informed drug development, biomarker development for precision medicine, master protocols in cancer research. This presentation intends to cover practical and challenging issues that are commonly seen in regulatory review and approval process and introduce FDA clinical initiatives regarding drug research and development.

Instructors’ Biography:

Shein-Chung Chow, Ph.D. is a Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, Durham, NC. Dr. Chow is also a special government employee (SGE) appointed by the FDA as an Advisory Committee voting member and Statistical Advisor to the FDA. Between 2017 and 2019, Dr. Chow was on leave for the Food and Drug Administration (FDA) as an Associate Director at Office of Biostatistics, Center for Drug Research and Evaluation (CDER), FDA. Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall and CRC Press, Taylor & Francis. Dr. Chow is Fellow of the American Statistical Association, who is the author or co-author of over 300 methodology papers and 30 books including Design and Analysis of Clinical Trials (Wiley & Sons), Adaptive Design Methods in Clinical Trials (Chapman and Hall/CRC Press), and most recently, Statistics in Regulatory Science (Chapman and Hall/CRC Press)

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