Abstract
Background: Since 2020, the number of registered clinical trials has surged by over 30%,
significantly increasing the demand for skilled coordinators. Despite this growth, a national
shortage of qualified coordinators remains, driven by escalating responsibilities and workloads.
Effective resource management is crucial for retention. While the Ontario Protocol Assessment
Level (OPAL) helps quantify trial complexity, it overlooks key factors such as organizational structure and budget constraints that impact coordinator productivity. This project aims to refine
the OPAL score by integrating it with longitudinal coordinator effort data, improving resource
allocation, operational efficiency, and job satisfaction, thereby reducing burnout and turnover.
Aim: The aim of this study was to reduce burnout and turnover, ultimately contributing to the
overall success of clinical trials.
Methods: Actively enrolling interventional studies with corresponding coordinator effort tracking
from June 1, 2022, to December 1, 2022, were included in the database. Protocols were graded
using an adapted protocol assessment tool. Descriptive statistics compared protocol characteristics to the adapted assessment score and tracked coordinator hours, while Student’s t-test and univariate
analysis evaluated differences in continuous variables. Linear regression analysis assessed the
association between the adapted score and the coordinator effort.
Results: Seven protocols were analyzed: five (71%) were federally funded, two (29%) were
industry-sponsored; four (57%) were behavioral interventions, and three (43%) were drug studies.
Significant differences were observed between industry-sponsored and federally funded studies
(7.25 ± 1.77 vs. 6.45 ± 1.65; P < 0.0001) and between behavioral interventions and drug studies
(6.88 ± 1.56 vs. 6.42 ± 1.91; P < 0.0001). Linear regression revealed the adapted OPAL score
significantly predicted coordinator hours (β = 77.22; P = 0.01; R2 = 0.78).
Conclusion: The adapted protocol complexity scores predict coordinator effort, aiding in capacity
assessment and objective project distribution.
Relevance for Patients: The findings from this project can inform more precise resource allocation,
potentially leading to higher-quality studies and enhanced participant safety.
DOI: https://doi.org/10.36922/jctr.24.00022
Author affiliation
1Clinical Research Center, Morehouse School of Medicine, Atlanta, Georgia, United States of America
2Department of Healthcare Leadership and
Management, College of Health Professions, Medical University of South Carolina, Charleston, South Carolina, United States of America
3South
Carolina Clinical and Translational Research Institute, College of Medicine, Medical University of South Carolina, Charleston, South Carolina,
United States of America
*Corresponding author:
Kesley Tyson
Clinical Research Center, Morehouse School
of Medicine, 720 Westview Drive SW,
Atlanta, Georgia 30331 United States of
America
Email: ktyson@msm.edu
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