Towards Formal Computable Representation of Clinical Trial Eligibility Criteria for Alzheimer’s Disease

Ambiguity and misunderstanding of free-text clinical trial eligibility can affect the accuracy of translating trial investigators’ mental model of the study population to the correct cohort identification queries. In this pilot study, to eliminate the ambiguity when parsing eligibility criteria, we built ontology-based representations to standardize clinical trial eligibility criteria. We analyzed 10 Alzheimer’s disease (AD) trials’ eligibility criteria and categorized them into general query patterns using an annotation schema borrowed from the literature on constructing knowledge graphs. Then, for each pattern, we built the corresponding ontological representations, linked them to real-word electronic health record (EHR) data, and constructed cohort identification queries using the neo4j graph database. Our evaluation results of these cohort queries verified the accuracy of our ontology representation; and interestingly, we found that graph-queries achieved better runtime performance for complex study traits. These results indicated that our approach is feasible and potentially beneficial; nevertheless, more systematic and comprehensive investigations are warranted. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study is funded in part by the National Insulites of Health (NIH) through awards: R21 AG068717 and R21 CA253394. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: IRB of University of Florida gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors