A maturity model for Clinical Trials Management Ecosystem

• Published in: Journal of clinical and translational science Vol. 9; no. 1; p. e28
• Main Authors: Sehgal, Shruti, Pua, E. Chris, Rojevsky, Svetlana, Becich, Michael J., Fehrmann, Joshua, Knosp, Boyd M., Wilcox, Adam, Talbert, Jeffery C., Craven, Catherine K., Starren, Justin
• Format: Journal Article
• Language: English
• Published: England Cambridge University Press 2025
• Subjects: clinical and translational research; Clinical trials; Clinical Trials Management Ecosystem; Collaboration; Consortia; Ecosystem management; Ecosystems; Electronic health records; Informatics; Information sharing; Leadership; Maturity; maturity models; Self evaluation; Software; Surveys; Working groups; clinical and translational research; Clinical Trials Management Ecosystem; clinical trials; informatics; maturity models
• ISSN: 2059-8661; 2059-8661
• DOI: 10.1017/cts.2024.1168

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. 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. 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. 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.