Clinical research informatics: challenges, opportunities and definition for an emerging domain

Abstract

Objectives: Clinical Research Informatics, an emerging sub-domain of Biomedical Informatics, is currently not well defined. A formal description of CRI including major challenges and opportunities is needed to direct progress in the field.

Design: Given the early stage of CRI knowledge and activity, we engaged in a series of qualitative studies with key stakeholders and opinion leaders to determine the range of challenges and opportunities facing CRI. These phases employed complimentary methods to triangulate upon our findings.

Measurements: Study phases included: 1) a group interview with key stakeholders, 2) an email follow-up survey with a larger group of self-identified CRI professionals, and 3) validation of our results via electronic peer-debriefing and member-checking with a group of CRI-related opinion leaders. Data were collected, transcribed, and organized for formal, independent content analyses by experienced qualitative investigators, followed by an iterative process to identify emergent categorizations and thematic descriptions of the data.

Results: We identified a range of challenges and opportunities facing the CRI domain. These included 13 distinct themes spanning academic, practical, and organizational aspects of CRI. These findings also informed the development of a formal definition of CRI and supported further representations that illustrate areas of emphasis critical to advancing the domain.

Conclusions: CRI has emerged as a distinct discipline that faces multiple challenges and opportunities. The findings presented summarize those challenges and opportunities and provide a framework that should help inform next steps to advance this important new discipline.

Figure 1

Overview of the four-phase methodology used to develop a systematic understanding of the definition, challenges and opportunities inherent to clinical research informatics (CRI).

Figure 2

Overview of identified themes organized into higher-level groupings by scope, and applied across the groups of stakeholders to which they apply. Of note is the fundamental and crosscutting nature of the frequently articulated theme labeled as Lessons not learned.

Figure 3

Illustration of types of research across which CRI is focused, and the relationships between CRI and the other sub-domains of translational bioinformatics, clinical informatics, and public health informatics. These relationships also parallel the focus areas and methodologies associated with the clinical and translational science paradigm, including the commonly referred to T1 and T2 blocks in translational capacity (where the T1 block is concerned with impediments to the translation of basic science discoveries into clinical studies, and the T2 block with the translation of clinical research findings into community practice).