A maturity model for Clinical Trials Management Ecosystem
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 institution...
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Cambridge University Press
2025-01-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124011683/type/journal_article |
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| author | Shruti Sehgal E. Chris Pua Svetlana Rojevsky Michael J. Becich Joshua Fehrmann Boyd M. Knosp Adam Wilcox Jeffery C. Talbert Catherine K. Craven Justin Starren |
| author_facet | Shruti Sehgal E. Chris Pua Svetlana Rojevsky Michael J. Becich Joshua Fehrmann Boyd M. Knosp Adam Wilcox Jeffery C. Talbert Catherine K. Craven Justin Starren |
| author_sort | Shruti Sehgal |
| collection | DOAJ |
| description |
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.
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| format | Article |
| id | doaj-art-f59634aeb01d435c8540c123bae61ca3 |
| institution | Kabale University |
| issn | 2059-8661 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj-art-f59634aeb01d435c8540c123bae61ca32025-02-05T07:06:28ZengCambridge University PressJournal of Clinical and Translational Science2059-86612025-01-01910.1017/cts.2024.1168A maturity model for Clinical Trials Management EcosystemShruti Sehgal0https://orcid.org/0000-0001-6352-8628E. Chris Pua1Svetlana Rojevsky2Michael J. Becich3https://orcid.org/0000-0001-5998-8074Joshua Fehrmann4Boyd M. Knosp5https://orcid.org/0000-0002-3834-3135Adam Wilcox6Jeffery C. Talbert7Catherine K. Craven8Justin Starren9Northwestern University Feinberg School of Medicine, Chicago, IL, USAVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USATufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USADepartment of Biomedical Informatics, School of Medicine, University of Pittsburgh, PA, USAClinical and Translational Science Institute, University of Minnesota, USARoy, J. and Lucille A. Carver College of Medicine and the Institute for Clinical & Translational Science, University of Iowa, Iowa City, IA, USA.Institute for Informatics, Data Science and Biostatistics, Department of Medicine, Washington University in St Louis, St Louis, MO, USAInstitute for Biomedical Informatics, University of Kentucky, Lexington, KY, USAUniversity of Texas Health Science Center San Antonio, San Antonio, TX, USAUniversity of Arizona, Tucson, AZ, USA 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. https://www.cambridge.org/core/product/identifier/S2059866124011683/type/journal_articleClinical Trials Management Ecosystemclinical trialsmaturity modelsinformaticsclinical and translational research |
| spellingShingle | Shruti Sehgal E. Chris Pua Svetlana Rojevsky Michael J. Becich Joshua Fehrmann Boyd M. Knosp Adam Wilcox Jeffery C. Talbert Catherine K. Craven Justin Starren A maturity model for Clinical Trials Management Ecosystem Journal of Clinical and Translational Science Clinical Trials Management Ecosystem clinical trials maturity models informatics clinical and translational research |
| title | A maturity model for Clinical Trials Management Ecosystem |
| title_full | A maturity model for Clinical Trials Management Ecosystem |
| title_fullStr | A maturity model for Clinical Trials Management Ecosystem |
| title_full_unstemmed | A maturity model for Clinical Trials Management Ecosystem |
| title_short | A maturity model for Clinical Trials Management Ecosystem |
| title_sort | maturity model for clinical trials management ecosystem |
| topic | Clinical Trials Management Ecosystem clinical trials maturity models informatics clinical and translational research |
| url | https://www.cambridge.org/core/product/identifier/S2059866124011683/type/journal_article |
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