Candidates will be taught skills to design and interpret equivalence trials, non-inferiority trials and cluster randomised trials. Specialised designs including enrichment and discontinuation designs will be discussed and special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite, co-primary and surrogate endpoints will be covered. Distinctions between event and chronological time directed outcomes will be discussed. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.
discussion groups and problem-based learning
2x short answer, some calculations quizzes (2x10%), 2x long answer assignments (2x40%)
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5001 and CLTR5007