Supporting formal expression of eligibility criteria in clinical trials. The implementation and evaluation of the eligibility criteria builder

Abstract

A clinical trial is a study that assesses the effectiveness and safety of a new drug or treatment. To be able to generalize from the findings of the study, the clinical trial requires a representative sample of the target patient population. The target population is defined in terms of eligibility criteria that clearly describe the characteristics of patients enrolled in the study. The eligibility criteria are stated in natural language in its own section in a protocol document, which serves as the plan and detailed description of any prospective clinical trial. Having the eligibility criteria expressed as natural language has several drawbacks. First, it can lead to ambiguities and different interpretations among clinicians responsible for enrolment of patients into the study, which consequently may affect the safety of patients. Second, it provides no means of automatic eligibility checking against patient databases and electronic patient journals. The process of determining the eligibility of each patient therefore becomes a resource demanding and time consuming task. Formally defined computer interpretable eligibility criteria could potentially improve safety of involved patients and efficiency in patient enrolment. This thesis presents the Eligibility Criteria Builder that aims to provide a simple and pragmatic way of defining these rules using a user-friendly graphical user interface. The evaluation of the prototype indicated that the target users in general were positive to, and clearly saw the need for, a tool like this. The evaluation also pointed out weak spots and areas of improvements for the proposed prototype.INFO390MASV-INF