Abstract
Background
The organization and operation of clinical trials have become increasingly complex requiring the coordination of a well-trained workforce to ensure that complicated protocols yield valid results that will advance human health. We hypothesized that formal education in clinical research is equivalent to a number of years of work experience as a clinical research professional in terms of self-perceived clinical research competence.
Methods
Using REDCap, we conducted a survey of students and recent graduates from academic programs in clinical research in the USA using the CICRP index that consists of 20 clinical research core competencies. We compared the responses of recent graduates to CRCs wording in the USA and Canada in various research settings who responded to a similar survey conducted by the Joint Task Force and to experienced CRCs working at research-intensive CTSA hubs and their affiliated hospitals who were surveyed as part of the NIH funded DIAMOND project.
Results
We found that the degree of self-perceived competence to perform advanced core competencies such as those related to regulatory affairs among new graduates of formal academic programs without research experience to be equivalent to as many as five years of on-the-job-training in a research-intensive CTSA setting and more than ten years of experience in less research-intensive community settings.
Conclusions
These findings suggest that scores on both forms of the CICRP differentiate CRCs according to formal education in clinical research, years of experience as a CRC and type of research setting in which they work. Further, the self-perceived competency assessed by CICRP acquired by completing an academic program in clinical research is equivalent to years of work experience.
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Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was partially supported through the National Center for the Advancement of Translational Science (NCATS) Clinical Translational Science Award (CTSA) Grant UL1TR002733, The Ohio State University Center for Clinical Translational Science. All statements in this report, including its findings and conclusions are solely those of the authors and do not necessarily represent the views of NCATS or the OSU CCTS. The funder supported the workforce development work of researchers but had no role in the conduct, analysis, or reporting of study findings.
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All authors had made contributions to this manuscript. JK performed data collection. CAH, JK, WG and CTJ conceptualized the study, the manuscript framework and editing. CAH and JK performed data analyses. CTJ and JC created figures. All authors reviewed and agreed to the final version.
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Conflict of interest
Carlton A. Hornung, Jared Kerr, William Gluck, Carolynn Thomas Jones have declared no financial conflicts of interest.
Ethical Approval
This study was deemed exempt from review by the University of North Carolina Wilmington Institutional Review Board.
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Hornung, C.A., Kerr, J., Gluck, W. et al. The Competency of Clinical Research Coordinators: The Importance of Education and Experience. Ther Innov Regul Sci 55, 1231–1238 (2021). https://doi.org/10.1007/s43441-021-00320-w
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DOI: https://doi.org/10.1007/s43441-021-00320-w