Introduction to Clinical Trials and Bayesian Designs

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This course will review major components of clinical trial conduct, including the formulation of clinical hypotheses and study endpoints, trial design, trial progress monitoring, analysis, and the summary and reporting of results. Bayesian statistics will be reviewed and some Bayesian adaptive designs will be presented along with a software demo. Lastly, flaws in existing clinical drug development will be reviewed with some solutions using Bayesian inference.

Course capacity: 30
Course fee: $10

Dates & Times

August 11th, 12th, & 13th: 10 AM – NOON

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Course Topics

• Major components of clinical trials; different phases of drug trials.
• Overview of Bayesian statistics and philosophy.
• Overview of statistical hypothesis testing and different philosophies on how tests and decisions are made.
• Introduction of Bayesian adaptive designs for early-phase clinical trials.
• Software demo and discussion on flaws of existing drug development.

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Instructor

Yuan Ji, Professor of Biostatistics, Department of Public Health Sciences

Dr. Yuan Ji graduated from Fudan University with a bachelor in Mathematics, University of Wisconsin – Madison with a PhD in Statistics. He spent 9 years at The University of Texas M. D. Anderson Cancer Center as Assistant and Associate Professor in Biostatistics and Bioinformatics. Currently, Dr. Yuan Ji is tenured Professor of Biostatistics at The University of Chicago. He is an NIH-funded PI focusing on innovative computational and statistical methods for translational cancer research. Dr. Ji is author of over 120 publications in peer-reviewed journals, conference papers, book chapters, and abstracts. He is the inventor of many innovative Bayesian adaptive designs such as the mTPI and mTPI-2 designs, which have been widely applied in dose-finding clinical trials. His recent work on precision medicine was elected as one of the top 10 ideas of the Precision Trials Challenge hosted by The Harvard Business School in 2015. He received the Mitchell price from the International Society of Bayesian Statistics in 2015. He is also a co-founder of Laiya Consulting, Inc., focusing on innovative and adaptive designs for clinical trials in new drug development, including the development of novel early-phase statistical platform allowing seamless and efficient clinical trials with master protocols.