• Evaluate how medicines perform in routine practice • Broad inclusion criteria; includes patients with other comorbidities • Requires expedited safety reporting to regulatory authorities • Randomisation to treatment strategy • Generally open-label • Treatment modifications# permitted, as occurs in routine practice • Safety data analysed by actual treatment • Individual clinicians are responsible for data collection with minimal review of patients | • Evaluate medicines under ideal and highly controlled conditions • Strict inclusion criteria; highly selected patient population • Requires expedited safety reporting to regulatory authorities • Randomisation to treatment groups • Generally double-blind • Treatment modifications# not permitted • Safety data analysed according to randomised treatment group • Multiple trained professionals are responsible for data collection with frequent patient reviews |