Evidence map›Paper›PMID 40693242›Full record

ArticleJournal of clinical and translational research2024

Resource management and capacity planning for clinical trial sites.

Kesley Tyson, Jillian Harvey, Leila Forney, Daniel Brinton

Abstract read
In one paragraph

Article in Journal of clinical and translational research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2026
    Article
  3. Scoping review of oncology clinical trials nursing: Roles, competencies, and evolving practice in cancer research.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2026
    Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Kesley TysonClinical Research Center, Morehouse School of Medicine, Atlanta, Georgia, United States of America.
Jillian HarveyDepartment of Healthcare Leadership and Management, College of Health Professions, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Leila ForneySouth Carolina Clinical and Translational Research Institute, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Daniel BrintonDepartment of Healthcare Leadership and Management, College of Health Professions, Medical University of South Carolina, Charleston, South Carolina, United States of America.

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Training the Trainers: Building Institutional Data Science Capacity to Support Health Disparities ResearchU54MD007602 · NIMHD · MOREHOUSE SCHOOL OF MEDICINE · PI Kevin Sean Kimbro · 2018 to 2026
$47.6M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR001450 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T., FLUME, PATRICK A · 2015 to 2024
$41.1M
Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)U24MD015970 · NIMHD · MOREHOUSE SCHOOL OF MEDICINE · PI Sandra Perreira Chang, Elizabeth O. Ofili · 2020 to 2026
$20.6M
NCATS NIH HHS UL1 TR001450NCATS NIH HHS UL1 TR002378NIMHD NIH HHS U24 MD015970NIMHD NIH HHS U54 MD007602
6 · The paper itself

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; 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.

Indexed as

Coordinator effortHistorically black college and universityOntario Protocol Assessment LevelOPAL scoreProtocol complexityWorkloads

Identifiers

PMID40693242
PMCPMC12279055

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.