Assessing the Competency of the Clinical Research Workforce: Formal Education; Role in the Research Enterprise; Research Setting; and Years of Experience
Presentation
Overview
Overview
Description
The organization and operation of clinical trials has become increasingly complex and will no doubt continue to do so with advances in the biomedical sciences and the omics revolution. Executing these trials will require the coordination of a well trained workforce to ensure that complicated protocols yield valid results that will advance human health. We report the development of core competencies and use data collected by the Joint Task Force on the Harmonization of Competencies for the Clinical Research Profession from a survey of research professionals working in the US and Canada (N=238). Factor analysis of 51 JTF core competencies was used to create the Competency Index for Clinical Research Professionals (CICRP-I; 20 competencies). CICRP-I consists of a General Index (10 items) and 4 sub-scales (Ethics and Participant Safety; Medicine's Development; Data Management; and Scientific Concepts). We found significant differences in self-perceived competence on the General Index as well as on Medicine's Development and the Ethics and Participant Safety scales between respondents in different clinical research roles with highest scores (i.e., higher perceived competence) reported by clinical research monitors (CRAs) followed by clinical research coordinators (CRCs) and the lowest scores reported by those whose roles were in data management. We also used data collected by the Development, Implementation and Assessment of Novel Training in Domain-Based Competencies project (DIAMOND) from experienced CRCs working at 4 research intensive CTSA hubs (N=95). Re-factoring the 20 CICRP-I items led to the creation of CICRP-II consisting of two indices: Routine Clinical Research Functions (10 competencies; i.e., GCPs) and Advanced Research Functions (10 competencies; e.g., Regulatory Affairs). We observed significantly lower CICRP-I and CICRP-II scores among CRCs working in a general research setting than those working in a research intensive CTSAs (P < 0.001). We next examined the relationship between CRCs self-perceived competency (CICRP-II) and formal education in a clinical research field, years of experience, and research setting. We used data collected from students graduating from a Consortium of Academic Programs in Clinical Research (CoAPCR) affiliated institution to compare recent graduates without clinical research experience to CRCs in community-based settings (JTF survey data) and CRCs at the CTSA sites (DIAMOND data). Competency in both Routine and Advanced Research Functions was unrelated to years of experience among CRCs at the CTSA sites but directly related to years of experience among CRCs at the less research intensive settings surveyed by the JTF. However, recent graduates without experience reported scores on Routine Functions equal to that of CRCs at the CTSA sites and higher than that of CRCs at the JTF sites. Moreover, recent graduates reported higher scores on Advanced Functions than both CTSA CRCs and JTF CRCs. These findings suggests that the self-perceived competency gained by formal education in an academic clinical research program is equivalent to years of experience in a research intensive setting.
