Building a library of eligibility criteria to support design of clinical trials

Abstract

The completion of clinical trial depends on sufficient participant enrollment, which is often problematic due to the restrictiveness of eligibility criteria, and effort required to verify patient eligibility. The objective of this research is to support the design of eligibility criteria, enable the reuse of structured criteria and to provide meaningful suggestions of relaxing them based on previous trials. The paper presents the first steps, a method for automatic comparison of criteria content and the library of structured and ordered eligibility criteria that can be browsed with the fine-grained queries. The structured representation consists of the automatically identified contextual patterns and semantic entities. The comparison of criteria is based on predefined relations between the patterns, concept equivalences defined in medical ontologies, and finally on threshold values. The results are discussed from the perspective of the scope of the eligibility criteria covered by our library. © 2012 Springer-Verlag.