Student-designed clinical trials: evaluating self-directed learning in pharmacology

Abstract. An evaluation exercise was developed for a third-year undergraduate problem-based course in pharmacology for science students. They were asked to design a clinical trial to evaluate a novel drug for an existing condition or an established drug for a novel condition. The exercise was assessed on both required elements (provision of a clear rationale, clear definition of outcome measures, patient inclusion/exclusion criteria, statistical analysis and critical assessment of available information) as well as on aesthetic elements (imagination, flair and readability). To promote self-directed learning, students were given minimal instructions and received no formal lectures on the subject of clinical trials. The exercise has been rated very highly by the students.