Designing a clinical trial. What should I care about?
Monday, 13 July (Melbourne City Centre) 9:00 am to 12:30 pm
A sound study design is of vital importance when conducting your research. Choices made at the design stage will drastically impact the results of your study. A design that has been thought through to the last detail and it is perfectly aligned with your research aims will have a better chance of producing useful evidence.
We will discuss in practical terms the fundamental elements to be considered in the planning and execution of controlled clinical trials designed to evaluate biomedical or behavioural interventions. Topics will include: target population definition, outcome/endpoint selection and measurement, randomization methods, blinding of intervention, risk of bias, attrition and post-randomization problems. The effect of features such as power, generalizability, validity, practicality and cost on the evidence provided by a trial will be discussed.
Using examples we will illustrate different types of designs including: completely and clustered randomized designs, cross-over and parallel designs, one-way and factorial designs, fixed and adaptive designs. We will also discuss the relative merits and feasibility of each approach. The close relationship between design and statistical analysis plan will be emphasized.
Who should attend?
PhD students and early career researchers within the Faculty of Health planning to conduct a clinical trial or a community intervention in order to answer their research questions.
Liliana Orellana, PhD, Associate Professor of Biostatistics