Epidemiology, Mathematical Foundations for Biostatistics
8-12 hours total study time per week
Assignments 100% (three written assignments, the first two worth 30% each and the final assignment worth 40%
Matthews JNS, Introduction to Randomized Controlled Clinical Trials, 2nd edition, Chapman and Hall 2006
R or Stata software
Topics include: ethical considerations; principles and methods of randomisation in controlled trials; treatment allocation, blocking, stratification and allocation concealment; parallel, factorial and crossover designs, including n-of-1 studies; practical issues in sample size determination; intention-to-treat principle; phase I dose finding studies; phase II safety and efficacy studies; interim analyses and early stopping; multiple outcomes/endpoints, including surrogate outcomes, multiple tests and subgroup analyses, including adjustment of significance levels and P-values; missing data; reporting trial results and use of the CONSORT statement.
Course notes, online mini-lecture videos, online tutorials, discussion board