Clinical research capability enhanced for medical undergraduates: an innovative simulation-based clinical research curriculum development

Background: Clinical research has frequently not been taught in a practical way, often resulting in a very didactic approach rendering it not very accessible for medical undergraduates. Simulation can provide an immersive, interactive, and reflective experience and may be applied to the clinical research curriculum. Methods: A 7-step model, modified from Kern's six-step approach and Khamis's stepwise model, was used to develop the curriculum. A questionnaire survey on undergraduates' attitude towards, knowledge and practice of clinical research and simulation education was conducted to generate a targeted needs assessment. The simulation framework was integrated into the development of educational strategies. Experts were consulted to assess the curriculum prior to implementation. Results: Talent construction in China needs an innovative capability-enhanced clinical research curriculum. Sixty-six clinical undergraduates in our school completed the survey. 89.39% (59/66) of them hadn't participated in clinical research, while 93.94% (62/66) would like to conduct clinical trials if possible. 75.76% of respondents didn't have knowledge of or practical abilities in clinical trials. The mean score for practical ability (2.02 +/- 0.92) was lower than that of knowledge (2.20 +/- 0.93) (P < 0.01). The dimension of case report form got the lowest score among the five dimensions. Participating in clinical research (P = 0.04) and learning for themselves (P < 0.01) by a few students may have increased the total score. The curriculum was designed to simulate the whole process from protocol writing, registration, ethical approval, implementation, and data analysis to reporting based on one case study, and was divided into two parts to simulate different types of research: randomized controlled trials and observational studies. It was conducted in semesters 5 and 7 respectively, both including 16 sessions. After expert consultation, one session having a 29.01% coefficient of variation was adjusted and replaced. The final simulation class design scenario scripts are provided for reference. Conclusions: The targeted needs assessment exposed medical undergraduates' poor knowledge of and abilities in clinical research. This is the first report of a simulation-based clinical research curriculum developed in China, and adds curriculum development and design details to the limited related published studies.