Course Director: Faculty
Pharmaceutical studies use many statistical methods that are not routinely taught as part of conventional biostatistics courses. In this course, the students will learn the statistical methods specifically used in pharmaceutical studies.
The course is divided into three modules.
(1) “Statistical Aspects of Phase I Clinical Trial” will include 3+3 Design, accelerated titration; up and down designs; continual reassessment method (CRM), Modified CRM, TITE CRM, Bayesian Logistic Regression Model (BLRM), escalation with overdose control (EWOC), toxicity probability interval (TPI) and modified TPI (mTPI).
(2) “Statistical Aspects of Phase II Clinical Trial” will include design and analyses for One stage and Simon’s Two Stage Designs, Multi-arm Phase II design.
(3) “Statistical Aspects of Phase III Clinical Trial” will include randomization, design and analysis for parallel, crossover, factorial, seamless Phase II/III, Adaptive and SMART designs.