PA-288 Study coordinator training programs should give attention to particular clinical trial knowledge and skill domains for a holistic set

• Published in: BMJ global health Vol. 8; no. Suppl 10; pp. A59 - A60
• Main Authors: Ejigu, Dawit, Fekadu, Abebaw, Makonnen, Eyasu
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd 17-12-2023; BMJ Publishing Group LTD
• Subjects: Abstracts of Poster and e-Poster Presentations; Clinical trials; Confidence; Skills
• ISSN: 2059-7908
• DOI: 10.1136/bmjgh-2023-EDC.146

BackgroundClinical trial knowledge and skills significantly influence the quality of clinical trial conduct. This article assesses the confidence of the ClinOps study coordinators’ training program trainees in the various clinical trial knowledge and skill domains. MethodsEighty-nine participants from 19 countries in Africa and South Korea participated in this cross-sectional study before commencing the training program for study coordinators. We assessed their confidence in several domains, such as clinical trial phases, regulations, ethics, data management, informed consent, project and financial management, internal and external team management, investigational product management, investigational site files (ISF), safety reporting, and patient recruitment and retention on five scales from “1” (Not Confident) to “5” (Extremely Confident). We compared the differences in confidence on various domains using the Kruskal Wallis test and pairwise Wilcoxon rank test with Bonferroni p-value adjustment. We also assessed factors associated with the baseline confidence of the trainees and the contribution of baseline confidence to a successful course completion using logistic regression, and Fisher’s exact test, respectively.ResultsConfidence in conducting a trial complying with ethical principles, informed consent process, securing approval, and managing ISF were relatively high among the trainees. However, the confidence of participants in financial, project, and external partner management, as well as closing out a trial was low. The differences in confidence in the various domains were statistically significant. After the training, the trainees’ confidence was significantly increased in all the domains, though the confidence in the four domains remained relatively low.ConclusionTraining efforts aiming to augment the knowledge and skills of study coordinators should give better attention to financial, project, and external partner management, as well as closing out a trial to ensure study coordinators with holistic clinical trial knowledge and skills.