Knowledge engineering for a clinical trial advice system: uncovering errors in protocol specification

ONCOCIN is an expert system that provides advice to physicians who are treating cancer patients enrolled in clinical trials. The process of encoding oncology protocol knowledge for the system has revealed serious omissions and unintentional ambiguities in the protocol documents. We have also discovered that many protocols allow for significant latitude in treating patients and that even when protocol guidelines are explicit, physicians often choose to apply their own judgment on the assumption that the specifications are incomplete. Computer-based tools offer the possibility of insuring completeness and reproducibility in the definition of new protocols. One goal of our automated protocol authoring environment, called OPAL, is to help physicians develop protocols that are free of ambiguity and thus to assure better compliance and standardization of care.