Clinical Trials

AY2017/2018 Semester 2

Phases of clinical trials, objectives and endpoints, the study cohort, controls, randomization and blinding, sample size determination, treatment allocation, monitoring trial progress: compliance, dropouts and interim analyses, monitoring for evidence of adverse or beneficial treatment effects, ethical issues, quality of life assessment, data analysis involving multiple treatment groups and endpoints, stratification and subgroup analysis, intent to treat analysis, analysis of compliance data, surrogate endpoints, multi-centre trials and good practice versus misconduct.