Clinical Research Integration Within the Electronic Health Record: A Literature Review

Abstract

Clinical trials have become commonplace as a treatment option. As clinical trial participants are integrated into all healthcare delivery settings, organizations are tasked with sustaining specific care regimens with appropriate documentation and maintenance of participant protections within electronic health records. Our aim was to identify the common elements necessary for electronic health record integration of clinical research for optimal trial conduct and participant management. Review of literature was conducted utilizing PubMed and CINAHL to identify relevant publications that described use of the electronic health record to directly support trial conduct, with a total of 15 publications ultimately meeting inclusion criteria. Three thematic groupings emerged that categorized common aspects of clinical research integration: functional, structural, and procedural components. These components include technological requirements (platform/system), regulatory and legal compliance, and stakeholder involvement with clinical trial procedures (recruitment of participants). Without a centralized means of providing clinicians with current treatment and adverse event management information, participant injury or likelihood of withdrawal will increase. Further research is required to develop an optimal model of research-related integration within commercial electronic health records.