Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials
Background: Quantifying workload for clinical trial staff represents an ongoing challenge for healthcare facilities conducting cancer clinical trials. We developed and evaluated a staffing model designed to meet this need. Methods: To address individual protocol acuity, the model's algorithms i...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-06-01
|
| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000596 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849470651295858688 |
|---|---|
| author | Ellen Siglinsky Hannah Phan Silviya Meletath Amber Neal David E. Gerber Asal Rahimi Erin L. Williams |
| author_facet | Ellen Siglinsky Hannah Phan Silviya Meletath Amber Neal David E. Gerber Asal Rahimi Erin L. Williams |
| author_sort | Ellen Siglinsky |
| collection | DOAJ |
| description | Background: Quantifying workload for clinical trial staff represents an ongoing challenge for healthcare facilities conducting cancer clinical trials. We developed and evaluated a staffing model designed to meet this need. Methods: To address individual protocol acuity, the model's algorithms include metrics to account for visit frequency, and the quantity, and types of research-related procedures. Since implementation in 2012, the model has been used to justify clinical research team resource needs and to establish metrics for leadership to reference when reviewing replacement positions; particularly useful to justify resources at the institutional level during the COVID-19 pandemic.In recent years, we identified a gap between predicted and actual staff workload. This precipitated a comprehensive review in 2021 of all aspects of scoring within the model including a comparison to modern protocols to ensure accounting for all types of protocol-related procedures and tests. Results: Further investigation identified increasing complexity of trial screening, which had not been accounted for in the initial model. Specifically, screening-related activities accounted for up to 25% of coordinator effort. We incorporated this work into the model and demonstrated a statistically significant change in average protocol acuity (P = 0.002) following refinement of scoring to include study-specific screening complexity. Conclusion: Over the past decade, cancer clinical trial screening has increased in complexity and duration. Planning a cancer center's clinical trial workforce requires consideration of screening-related staff effort. For any effort model to be successful, ongoing examination and malleability are critical in this evolving landscape of clinical trials. |
| format | Article |
| id | doaj-art-7a6b7b85c9104f92973267f3648a9cf6 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-7a6b7b85c9104f92973267f3648a9cf62025-08-20T03:25:05ZengElsevierContemporary Clinical Trials Communications2451-86542025-06-014510148510.1016/j.conctc.2025.101485Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trialsEllen Siglinsky0Hannah Phan1Silviya Meletath2Amber Neal3David E. Gerber4Asal Rahimi5Erin L. Williams6Corresponding author. University of Texas Southwestern Medical Center 6202 Harry Hines Blvd, NM8.802, Dallas, TX, 75235, United States.; University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, United StatesBackground: Quantifying workload for clinical trial staff represents an ongoing challenge for healthcare facilities conducting cancer clinical trials. We developed and evaluated a staffing model designed to meet this need. Methods: To address individual protocol acuity, the model's algorithms include metrics to account for visit frequency, and the quantity, and types of research-related procedures. Since implementation in 2012, the model has been used to justify clinical research team resource needs and to establish metrics for leadership to reference when reviewing replacement positions; particularly useful to justify resources at the institutional level during the COVID-19 pandemic.In recent years, we identified a gap between predicted and actual staff workload. This precipitated a comprehensive review in 2021 of all aspects of scoring within the model including a comparison to modern protocols to ensure accounting for all types of protocol-related procedures and tests. Results: Further investigation identified increasing complexity of trial screening, which had not been accounted for in the initial model. Specifically, screening-related activities accounted for up to 25% of coordinator effort. We incorporated this work into the model and demonstrated a statistically significant change in average protocol acuity (P = 0.002) following refinement of scoring to include study-specific screening complexity. Conclusion: Over the past decade, cancer clinical trial screening has increased in complexity and duration. Planning a cancer center's clinical trial workforce requires consideration of screening-related staff effort. For any effort model to be successful, ongoing examination and malleability are critical in this evolving landscape of clinical trials.http://www.sciencedirect.com/science/article/pii/S2451865425000596StaffingEffort reportingClinical trialOncologyStaff Retention |
| spellingShingle | Ellen Siglinsky Hannah Phan Silviya Meletath Amber Neal David E. Gerber Asal Rahimi Erin L. Williams Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials Contemporary Clinical Trials Communications Staffing Effort reporting Clinical trial Oncology Staff Retention |
| title | Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials |
| title_full | Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials |
| title_fullStr | Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials |
| title_full_unstemmed | Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials |
| title_short | Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials |
| title_sort | design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials |
| topic | Staffing Effort reporting Clinical trial Oncology Staff Retention |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000596 |
| work_keys_str_mv | AT ellensiglinsky designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials AT hannahphan designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials AT silviyameletath designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials AT amberneal designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials AT davidegerber designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials AT asalrahimi designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials AT erinlwilliams designandrefinementofaclinicaltrialstaffingmodelwithintheevolvinglandscapeofoncologyclinicaltrials |