Oncology thinking cap: Scaffolded use of a simulation to learn clinical trial design

Background: Physicians often are called on to participate in and interpret clinical trials, but their training in this area may not provide them with the inquiry skills that are needed. Simulations have the potential to be a promising tool for helping medical students learn the skills involved in cl inical trial design. However simulations may be complex and require additio nal scaffolding to support learning. Description: The goal of this study was to teach aspects of cancer clinical trial design through the scaffolded use of a simulation, the Oncology Thin king Cap. The software-based scaffolding provided guidance in designing the trial. Subsequently, the simulation allowed students to run the designed t rial, which produces detailed patient histories. This feedback then could b e used to redesign the trial. Evaluation: Twenty-four 4th-year medical students were asked to design a cl inical trial in advance, on paper to test a new anticancer drug. Student gr oups then designed and simulated running the clinical trial assisted by the software environment. Instructional effectiveness was measured using a pre test-posttest design that included having students (a) write a group resear ch proposal and (b) individually critique a flawed proposal. At the group l evel (N = 6 groups), students demonstrated a 34% increase in the number of elements of a clinical trial that they included in their research proposals . At the individual level (N = 24), students improved by 48% in their criti ques of flawed proposals Conclusions: Scaffolding embedded in the simulator is a promising approach to helping students learn about clinical trial design. Copyright (C) 2001 b y Lawrence Erlbaum Associates, Inc.