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. 2025 Jan 22;9(1):e28.
doi: 10.1017/cts.2024.1168. eCollection 2025.

A maturity model for Clinical Trials Management Ecosystem

Shruti Sehgal  1 , E Chris Pua  2 , Svetlana Rojevsky  3 , Michael J Becich  4 , Joshua Fehrmann  5 , Boyd M Knosp  6 , Adam Wilcox  7 , Jeffery C Talbert  8 , Catherine K Craven  9 , Justin Starren  10
Affiliations

A maturity model for Clinical Trials Management Ecosystem

Shruti Sehgal et al. J Clin Transl Sci. .

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.

Keywords: Clinical Trials Management Ecosystem; clinical and translational research; clinical trials; informatics; maturity models.

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Conflict of interest statement

The authors declare that they have no relevant competing interests to declare.

Figures

Figure 1.
Figure 1.
Process diagram illustrating the steps in the development of the Clinical Trials Management Ecosystem maturity model. CTSA = Clinical and Translational Science Award, CTM = clinical trials management, CTME = Clinical Trials Management Ecosystem, IRB = Institutional Review Board.
Figure 2.
Figure 2.
Institutional responses (n = 23) to the CTME maturity model self-assessment. CTME = Clinical Trials Management Ecosystem.
Figure 3.
Figure 3.
Figure depicting the maturity of institutions by axis with regard to the CTME. CTME = Clinical Trials Management Ecosystem.
Figure 4.
Figure 4.
Figure illustrating the evolution of maturity for the “Data” axis of the CTME maturity model. Note: the illustration represents maturity statements clustered around one conceptual component only, standardization. The figure does not represent maturity statements for complexity/integration and monitoring. CTME = Clinical Trials Management Ecosystem.
See this image and copyright information in PMC

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