Course overview
Principles in research studies with humans in the health and medical sciences will be examined by considering the interpretation and critical appraisal of conventional and controversial publications of studies using the CONSORT guidelines which will be built upon throughout the course. Features of 'gold standard' randomised controlled trials will be showcased to demonstrate how knowledge of their principles can translate to effective and meaningful design, analysis, and robust results for other experiments while acknowledging their limitations and potential biases. Practical skills in the statistical analysis of results will also be developed in this course. These topics will include the construction of research hypotheses, principles of statistical inference, confidence interval estimation, and differences in statistical approaches in the clinical trials setting. Students will undertake analyses of study data where outcomes are continuous or binary, and understand the role of univariable and adjusted analyses. Students will carry out sample size calculations appropriate to different study designs and continue to consider the relevance of all CONSORT guidelines in the context of motivating real-life studies with humans.
Course learning outcomes
- Apply common clinical trial design features appropriately in addressing research questions
- Distinguish between primary and secondary outcome variables and demonstrate knowledge of different types of variables
- Apply a range of simple and complex statistical analysis techniques commonly used in clinical trials, including intention to treat, per protocol and as treated approaches
- Demonstrate statistical reasoning skills correctly with unadjusted and adjusted parallel group analyses
- Interpret and communicate critiques of published literature against the CONSORT statement
- Use 'Stata' statistical software proficiently to conduct unadjusted and adjusted parallel group analyses and interpret relevant output