Journal of clinical and translational research最新文献

{"title":"Prospective evaluation of the adapted Ontario Protocol Assessment Level score for predicting clinical research coordinator workload: An internal validation study.","authors":"Kesley Holmes, Muhammed Idris, Jillian Harvey, Leila Forney, Daniel Brinton, Jan Morgan Billingslea, Priscilla Pemu","doi":"10.36922/jctr025260032","DOIUrl":"10.36922/jctr025260032","url":null,"abstract":"<p><strong>Background: </strong>The escalating complexity of clinical trial protocols has considerably increased the workload for research coordinators, exacerbating staffing shortages and contributing to operational inefficiencies. These challenges are particularly pronounced at under-resourced and minority-serving research institutions, where limited capacity may hinder the implementation of trials. Early and accurate estimation of research coordinator effort is essential for effective planning, resource management, and successful clinical trial conduct.</p><p><strong>Aim: </strong>This study assesses the accuracy of an adopted Ontario Protocol Assessment Level (OPAL) score in predicting coordinator workload to improve operational planning in clinical research.</p><p><strong>Methods: </strong>A prospective observational study was conducted over a 12-month period at a Historically Black College and University medical school. Seven coordinators recorded hours for seven actively enrolling interventional trials. Estimated workloads were calculated using a published, adapted OPAL reference table, and were compared with actual hours using descriptive statistics and paired <i>t</i>-tests. To ensure consistent benchmarking, workday equivalencies (7.5 h for institutional standards and 8 h for industry standards) were applied.</p><p><strong>Results: </strong>There was no statistically significant difference between estimated and actual hours, with an average difference of 24.1 h (<i>p</i>=0.761). The mean absolute error was 167.0 h, equivalent to roughly 1 month of full-time work.</p><p><strong>Conclusion: </strong>The adapted OPAL score provides a practical tool for estimating coordinator workload and aligning staffing with protocol complexity, including in under-resourced settings. However, broader multi-site validation is required to confirm its generalizability and to support its integration into feasibility planning.</p><p><strong>Relevance for patients: </strong>Accurate workload forecasting enhances trial efficiency, supporting timely, high-quality studies, and accelerating access to new treatments.</p>","PeriodicalId":520953,"journal":{"name":"Journal of clinical and translational research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413211/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A scaffolded training series to develop Clinical and Translational Researchers in Hawai'i.","authors":"Merle Kataoka-Yahiro, F David Horgen, Dedra Buchwald, Claire Townsend Ing, Spero M Manson, Joseph Keawe'aimoku Kaholokula, Kathryn L Braun","doi":"10.1017/cts.2025.10108","DOIUrl":"10.1017/cts.2025.10108","url":null,"abstract":"<p><p>We describe a training series using a scaffolded approach informed by Vygotsky's Learning Theory to advance Hawai'i -based faculty grant-writing skills. Sponsored by the Professional Development Core of the Center for Pacific Innovations, Knowledge, and Opportunities (PIKO) at the University of Hawai'i at Mānoa, the initiative includes a 2-week series of 1-hour introductory sessions on aspects of grant writing, a 3-session workshop to develop a specific aims page, and a 5-month training program in grant writing. Over three years, 202 Hawai'i investigators attended at least one 1-hour introductory session, 62 completed the workshop on preparing specific aims, and 30 completed the 5-month training on grant writing. Participants rated all 3 programs as very useful. Of the 62 unique investigators who completed the Specific Aims Workshop, 21 (33%) submitted PIKO pilot grant applications, 4 (6%) submitted grants elsewhere, and 16 (30%) applied to the 5-month training on grant writing. The 30 GUMSHOE participants reported significant gains in their confidence in accomplishing 21 proposal-writing tasks and, as of May 2025, 26 (87%) submitted grants to the National Institutes of Health or another external funder. This scaffolded training approach is labor- and time-intensive for trainees and faculty mentors, but our outcomes demonstrate its success.</p>","PeriodicalId":520953,"journal":{"name":"Journal of clinical and translational research","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12452898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145133019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Resource management and capacity planning for clinical trial sites.","authors":"Kesley Tyson, Jillian Harvey, Leila Forney, Daniel Brinton","doi":"10.36922/jctr.24.00022","DOIUrl":"10.36922/jctr.24.00022","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aim: </strong>The aim of this study was to reduce burnout and turnover, ultimately contributing to the overall success of clinical trials.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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; <i>P</i> < 0.0001) and between behavioral interventions and drug studies (6.88 ± 1.56 vs. 6.42 ± 1.91; <i>P</i> < 0.0001). Linear regression revealed the adapted OPAL score significantly predicted coordinator hours (<i>β</i> = 77.22; <i>P</i> = 0.01; <i>R</i> ² = 0.78).</p><p><strong>Conclusion: </strong>The adapted protocol complexity scores predict coordinator effort, aiding in capacity assessment and objective project distribution.</p><p><strong>Relevance for patients: </strong>The findings from this project can inform more precise resource allocation, potentially leading to higher-quality studies and enhanced participant safety.</p>","PeriodicalId":520953,"journal":{"name":"Journal of clinical and translational research","volume":"10 4","pages":"229-236"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12279055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144684043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}