Study Design in Clinical Research (CLRS90011)

Identifying the most appropriate study design is important for generating the best evidence to answer a clinical research question. A well-designed study will clearly identify a range of variables including the participant population, the intervention or exposure of interest and the outcomes to be investigated and how data will be collected. Understanding the various indications for different study designs is important for not only devising a new study but also for critically reviewing published studies.

This subject will provide students with an in-depth understanding of the principles and application of a variety of study designs in a clinical/medical setting. Key areas that will be covered include:

1. examining the range of quantitative, qualitative and mixed-methods approaches such as

• experimental and quasi-experimental, cohort, cross-sectional and single-subject designs;
• participant observation, in-depth interviews, case-studies, focus groups and artefact analysis designs;
• screening, preventive and genetic/biomarker trials
• construction and administration of surveys and questionnaires and;
• the use of clinical bioinformatics, e-health and large population datasets.

2. strategies for matching study aims/objectives with selection of an appropriate study design
3. exploring sources of bias in research such as randomization, allocation, concealment and blinding and their relationship to the principles of internal and external validity
4. using published reporting guidelines (eg CONSORT statement) to aid in the design and reporting of a study
5. participant recruitment/retention/attrition, outcome measure selection and the application of power calculations
6. the principles of drug evaluation and regulation