In this short course, we will discuss the opportunities and challenges in biomarker utilization and personalized medicine, covering both classical and adaptive designs with biomarkers. the biomarker utilities in the adaptive design settings will include biomarker enrichment design, biomarker-informed adaptive design with single-level and hierarchical biomarker models. Various classical and adaptive dose-finding trial designs will be compared, including classic Dunnett procedure, drop-loser and add-arm designs. The application of biomarker in multiple-group dose-finding adaptive design will also be explored. Examples and simulation programs in SAS and R will be provided. By attending this session, participants will learn some recent developments in biomarker study from statistical perspective and share their experiences and practical problems concerning the biomarker utility in drug development.
Mark Chang, Ph.D.
Mark Chang is Vice President, Biometrics; AMAG, an adjunct professor of Boston University and an elected ASA Fellow. He is a co-founder of the International Society for Biopharmaceutical Statistics. He was a co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group. His publications include 8 books in biostatistics and adaptive clinical trial designs.
