Using the Smiley Faces task to teach the fundamentals for good clinical trials

Background: Many factors need to be considered when designing a clinical trial. Although structures such as PICOT (Population, Intervention, Comparator, Outcome, Timeline) are helpful, people with little or no prior knowledge can find designing and implementing a trial to be overly complicated. We developed a simple exercise to illustrate key features of trials: the Smiley Faces task. Aim: We describe how the Smiley Faces task can demonstrate the importance of good planning of trials and highlight pitfalls. Method and Results: The Smiley Faces task is centred on the simple, intuitive task to "draw a smiley face". It requires no existing knowledge about trials or research generally, but can be used to highlight key features of a trial; such as formulating the research question; planning for coding, collection and analysis of data; handling of missing data and drawing of conclusions. We present insights from conducting the exercise dozens of times and collecting hundreds of smiley face drawings in a range of educational settings. Conclusion: The simplicity and accessibility of the task makes it relatively easy to demonstrate key points for careful planning of clinical trials. The approach is generalizable and applicable to researchers and teachers in a variety of medical settings.