DEVELOPMENT OF DESIGN-A-TRIAL, A KNOWLEDGE-BASED CRITIQUING SYSTEM FOR AUTHORS OF CLINICAL-TRIAL PROTOCOLS

Many published clinical trials are poorly designed, suggesting that th e protocol was incomplete, disorganised or contained errors. This fact , doctors' limited statistical skills and the shortage of medical stat isticians, prompted us to develop a knowledge-based aid, Design-a-Tria l, for authors of clinical trial protocols. This interviews a physicia n, prompts them with suitable design options, comments on the statisti cal rigour and feasibility of their proposed design and generates a 6- page draft protocol document, This paper outlines the process used to develop Design-a-Trial, presents preliminary evaluation results, and d iscusses lessons we learned which may apply to the developers of other medical decision-aids.