The gives knowledge of common study designs in clinical trials. The student will become familiar with statistical analyses that are appropriate for the different designs covered in the course, and will be able to perform them using software packages. The course includes:
- the clinical trial protocol,
- sources of bias in clinical trials,
- blinding, randomization, sample size calculation;
- design and analysis of phase I, phase II, phase III and hybrid trials;
- interim analysis, non-inferiority studies;
- stochastic curtailment, Bayes designs, and administrative issues in study design.
Calculus-based probability and mathematical statistics will be used throughout. Many area of statistical inference can be useful in the context of clinical trials (categorical methods, linear models, mixed models, survival analysis etc). Because of that, the more knowledge the student have the better he or she will be able to assimilate the content of this course.
This course is given
- every second year
- in the first half of spring
- jointly with Chalmers MVE200
Course information 2012
Course information 2010
Course information 2008