Course overview
This course introduces the principles underlying the ethical design, conduct, analysis, interpretation, and reporting of randomised controlled trials in health and medical research. Using real trial examples, it examines how experimental studies with humans generate evidence used in clinical and public-health decision making, including when and why randomised trials may be limited or inappropriate. Core features of well-designed trials, including randomisation, appropriate comparison groups, transparent reporting guided by CONSORT principles, and sound statistical analysis, are examined. Through online content, workshops, and practicals using Stata, students develop practical skills to analyse trial data and critically evaluate evidence to support thoughtful, evidence-based decision making.
- RCTs: Foundations and Standards
- Designing Robust RCTs
- Analysing Treatment Effects
- Adjustment & Beyond Primary Analysis
- Reporting & Interpreting Results
Course learning outcomes
- Explain the fundamental principles underpinning randomised controlled trials, and why these are essential for causal inference.
- Apply core design principles to define appropriate populations, interventions, comparators, outcomes, hypotheses, and analysis principles for randomised controlled trials.
- Analyse and interpret data from randomised controlled trials using appropriate statistical methods and statistical software (Stata).
- Critically evaluate trials against the CONSORT guidance.
- Judge the generalisability and real-world relevance of trial evidence, including distinctions between efficacy and effectiveness and implications for policy, practice, and public-health decision-making.
- Interpret evidence from experimental studies, articulating design rationale, statistical reasoning, and conclusions appropriate for scientific and public-health audiences.