Clinical deployment of a medical expert system to increase accruals for clinical trials: Challenges

Before new medical treatments become available to the public, clinicians must conduct extensive trials to determine the efficacy of the novel therapy. In order for the clinical trial to be successful, a significant number of patients with an appropriate set of medical conditions must be accrued. We have implemented a web-based expert system at the H. Lee Moffitt Cancer Center & Research Institute in the Gastrointestinal Tumor Clinic (GITC) to help physicians screen patients for phase II trials. Our system allows physicians to screen a patient for multiple trials simultaneously. Our experiments have shown that adaptation of the system into a clinical environment and the success of the system are related to the amount of time physicians are willing to spend entering data. We also found significant regulatory issues (HIPAA) that make implementation challenging.