A maturity model for Clinical Trials Management Ecosystem

Authors

• Shruti Sehgal, Northwestern University
• E. Chris Pua, Vanderbilt University
• Svetlana Rojevsky, Tufts University
• Michael J. Becich, University of Pittsburgh
• Joshua Fehrmann, University of Minnesota Twin Cities
• Boyd M. Knosp, University of Iowa Carver College of Medicine
• Adam Wilcox, Washington University School of Medicine in St. Louis
• Jeffery C. Talbert, University of KentuckyFollow
• Catherine K. Craven, The University of Texas Health Science Center at San Antonio
• Justin Starren, University of ArizonaFollow

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.

Document Type

Article

Publication Date

1-22-2025

Notes/Citation Information

Publisher Copyright: © The Author(s), 2025.

Digital Object Identifier (DOI)

10.1017/cts.2024.1168

Archival?

Archival

Repository Citation

Sehgal, Shruti; Pua, E. Chris; Rojevsky, Svetlana; Becich, Michael J.; Fehrmann, Joshua; Knosp, Boyd M.; Wilcox, Adam; Talbert, Jeffery C.; Craven, Catherine K.; and Starren, Justin, "A maturity model for Clinical Trials Management Ecosystem" (2025). Biostatistics Faculty Publications. 125.
https://uknowledge.uky.edu/biostatistics_facpub/125