Page 7 - JCTR-10-4

Journal of Clinical and Translational Research 2024; 10(4): 229-236

Journal of Clinical and Translational Research

Journal homepage: http://www.jctres.com/en/home

ORIGINAL ARTICLE

Resource management and capacity planning for clinical trial sites

Kesley Tyson *, Jillian Harvey , Leila Forney , Daniel Brinton 2
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1 Clinical Research Center, Morehouse School of Medicine, Atlanta, Georgia, United States of America, Department of Healthcare Leadership and
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Management, College of Health Professions, Medical University of South Carolina, Charleston, South Carolina, United States of America, South
3
Carolina Clinical and Translational Research Institute, College of Medicine, Medical University of South Carolina, Charleston, South Carolina,
United States of America
ARTICLE INFO ABSTRACT

Article history: Background: Since 2020, the number of registered clinical trials has surged by over 30%,
Received: May 31, 2024 significantly increasing the demand for skilled coordinators. Despite this growth, a national
Accepted: July 31, 2024 shortage of qualified coordinators remains, driven by escalating responsibilities and workloads.
Published Online: August 20, 2024 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
Keywords: structure and budget constraints that impact coordinator productivity. This project aims to refine
Protocol complexity the OPAL score by integrating it with longitudinal coordinator effort data, improving resource
Workloads allocation, operational efficiency, and job satisfaction, thereby reducing burnout and turnover.
Ontario Protocol Assessment Level Aim: The aim of this study was to reduce burnout and turnover, ultimately contributing to the
OPAL score overall success of clinical trials.
Coordinator effort Methods: Actively enrolling interventional studies with corresponding coordinator effort tracking
Historically black college and university 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
*Corresponding author: to the adapted assessment score and tracked coordinator hours, while Student’s t-test and univariate
Kesley Tyson analysis evaluated differences in continuous variables. Linear regression analysis assessed the
Clinical Research Center, Morehouse School association between the adapted score and the coordinator effort.
of Medicine, 720 Westview Drive SW, Results: Seven protocols were analyzed: five (71%) were federally funded, two (29%) were
Atlanta, Georgia 30331 United States of industry-sponsored; four (57%) were behavioral interventions, and three (43%) were drug studies.
America Significant differences were observed between industry-sponsored and federally funded studies
Email: ktyson@msm.edu (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
© 2024 Author(s). This is an Open- significantly predicted coordinator hours (β = 77.22; P = 0.01; R = 0.78).
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Access article distributed under the terms Conclusion: The adapted protocol complexity scores predict coordinator effort, aiding in capacity
of the Creative Commons Attribution-
Noncommercial License, permitting all assessment and objective project distribution.
non-commercial use, distribution, and Relevance for Patients: The findings from this project can inform more precise resource allocation,
reproduction in any medium, provided the potentially leading to higher-quality studies and enhanced participant safety.
original work is properly cited.

1. Introduction
Despite a failure rate of approximately 90%, the number of clinical trials conducted
has continued to grow consistently over time [1]. According to ClinicalTrials.gov, there
has been over a 30% increase in registered clinical trials since 2020 [2]. The increase
in the number of trials has also brought about greater complexity. Contributing factors
include more frequent protocol amendments and the challenges of shifting to remote
studies during the COVID-19 pandemic. These factors have not only added to the
complexity but also escalated study costs, caused delays, and increased regulatory
burdens. Moreover, sites that primarily serve underrepresented communities face unique
DOI: https://doi.org/10.36922/jctr.24.00022