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 the protocol was incomplete, disorganised or contained errors. This fact, doctors' limited statistical skills and the shortage of medical statisticians, prompted us to develop a knowledge-based aid, Design-a-Trial, for authors of clinical trial protocols. This interviews a physician, prompts them with suitable design options, comments on the statistical 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 discusses lessons we learned which may apply to the developed of other medical decision-aids.