Clinical Research Informatics: a Decade-in-Review.

Background: Clinical Research Informatics (CRI) is a subspeciality of biomedical informatics that has substantially matured during the last decade. Advances in CRI have transformed the way clinical research is conducted. In recent years, there has been growing interest in CRI, as reflected by a vast and expanding scientific literature focused on the topic. The main objectives of this review are: 1) to provide an overview of the evolving definition and scope of this biomedical informatics subspecialty over the past 10 years; 2) to highlight major contributions to the field during the past decade; and 3) to provide insights about more recent CRI research trends and perspectives.

Methods: We adopted a modified thematic review approach focused on understanding the evolution and current status of the CRI field based on literature sources identified through two complementary review processes (AMIA CRI year-in-review/IMIA Yearbook of Medical Informatics) conducted annually during the last decade.

Results: More than 1,500 potentially relevant publications were considered, and 205 sources were included in the final review. The review identified key publications defining the scope of CRI and/or capturing its evolution over time as illustrated by impactful tools and methods in different categories of CRI focus. The review also revealed current topics of interest in CRI and prevailing research trends.

Conclusion: This scoping review provides an overview of a decade of research in CRI, highlighting major changes in the core CRI discoveries as well as increasingly impactful methods and tools that have bridged the principles-to-practice gap. Practical CRI solutions as well as examples of CRI-enabled large-scale, multi-organizational and/or multi-national research projects demonstrate the maturity of the field. Despite the progress demonstrated, some topics remain challenging, highlighting the need for ongoing CRI development and research, including the need of more rigorous evaluations of CRI solutions and further formalization and maturation of CRI services and capabilities across the research enterprise.