Study design

This branch covers how studies are designed to answer research questions, divided into the choice among designs, the design and analysis of clinical trials, and evidence drawn from routine care. It leaves statistical methods in general, outcome measurement, appraisal of completed studies and writing a clinical study protocol to neighbouring branches.

• Study designs and the questions they answer — matching questions to intervention, observational, qualitative and mixed-methods designs, reviews and evidence hierarchies
• Designing and analysing clinical trials — treatment questions, estimands, trial populations, alternative trial methods, missing data, analysis planning and disease- or product-specific settings
• Real-world evidence — data sources, lifecycle and drug-safety uses, regulatory assessment, analysis, artificial intelligence, data integrity and reporting