Journal article
A Maturity Model for Clinical Trials Management Ecosystem
Journal of clinical and translational science, Vol.9(1), e28
01/22/2025
DOI: 10.1017/cts.2024.1168
Abstract
Introduction:
Managing clinical trials is a complex process requiring careful integration of human, technology, compliance, and operations for success. We collaborated with experts to develop a multi-axial Clinical Trials Management Ecosystem (CTME) maturity model (MM) to help institutions identify best practices for CTME capabilities.
Methods:
A working group of research informaticists was established. An online session on maturity models was hosted, followed by a review of the candidate domain axes and finalization of the axes. Next, maturity level attributes were defined for min/max levels (level 1 and level 5) for each axis of the CTME MM, followed by the intermediate levels. A REDCap survey comprising the model’s statements was then created, and a subset of working group members tested the model by completing it at their respective institutions. The finalized survey was distributed to all working group members.
Results:
We developed a CTME MM comprising five maturity levels across 11 axes: study management, regulatory and audit management, financial management, investigational product management, subject identification and recruitment, subject management, data, reporting analytics & dashboard, system integration and interfaces, staff training & personnel management, and organizational maturity and culture. Informaticists at 22 Clinical and Translational Science Award hubs and one other organization self-assessed their institutional CTME maturity. Respondents reported relatively high maturity for study management and investigational product management. The reporting analytics & dashboard axis was the least mature.
Conclusion:
The CTME MM provides a framework to research organizations to evaluate their current clinical trials management maturity across 11 axes and identify areas for future growth.
Details
- Title: Subtitle
- A Maturity Model for Clinical Trials Management Ecosystem
- Creators
- Shruti SehgalE. Chris Pua - Vanderbilt University Medical CenterSvetlana Rojevsky - Tufts UniversityMichael J Becich - University of PittsburghJoshua Fehrmann - University of MinnesotaBoyd M. Knosp - University of IowaAdam Wilcox - Washington University in St. LouisJeffery C. Talbert - University of KentuckyCatherine K. Craven - The University of Texas Health Science Center at San AntonioJustin Starren - University of Arizona
- Resource Type
- Journal article
- Publication Details
- Journal of clinical and translational science, Vol.9(1), e28
- Publisher
- CAMBRIDGE UNIV PRESS
- DOI
- 10.1017/cts.2024.1168
- ISSN
- 2059-8661
- eISSN
- 2059-8661
- Number of pages
- 29
- Grant note
- Center for Leading Innovation and Collaboration (CLIC)
We are thankful to the Center for Leading Innovation and Collaboration (CLIC) and Informatics Enterprise Committee (IEC) for their assistance with workgroup meetings.
- Language
- English
- Date published
- 01/22/2025
- Academic Unit
- Medicine Administration
- Record Identifier
- 9984781373102771
Metrics
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