Insights from the trial innovation network’s initial consultation process

Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health's National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial's duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator's institution. The Initial Consultation process focuses on the study's scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

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Journal
Journal of Clinical and Translational Science
Published
2025-01-01
DOI
https://doi.org/10.1017/cts.2025.10084
Primary Topic
Health and Medical Research Impacts
Type
article
Field-Weighted Citation Impact
0.00

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article

Insights from the trial innovation network’s initial consultation process

W. Andrew Mould, Dixie D. Thompson, Karen Lane, Jonathan D. Casey et al.
Journal of Clinical and Translational Science
Health and Medical Research Impacts
article

Insights from the trial innovation network’s initial consultation process

W. Andrew Mould, Dixie D. Thompson, Karen Lane, Jonathan D. Casey, Sara Hassani, Paul A. Harris, Marisha E. Palm, James F. Casella, Nichol McBee, Emily S. Serdoz, Terri Edwards, Sarah J. Nelson, Nan Kennedy, Colleen Lawrence, Daniel F. Hanley, Jay B. Dean, Mary Stroud, Lori Poole, Michelle Jones, Mariela Rodriguez, Gordon R. Bernard, Salina P. Waddy, Angeline Nanni, Edgar R. Miller, Jessica F. Baird, Consuelo H. Wilkins, Daniel E. Ford, Natalie A. Dilts, Joseph Christodoulou, Meghan Hildreth, Harry P. Selker, Tiffany Chen, Maeve Tischbein, Daniel K. Benjamin, Leslie R. Boone, Jeri Burr, Sarah K. Cook, Amna Baig, Lindsay M. Eyzaguirre, Jodie Cohen, Ken Wiley, Delicia Burts, Elizabeth Holthouse, Natalya Amrine, LaShondra Deyampert
article en

Abstract

Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health's National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial's duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator's institution. The Initial Consultation process focuses on the study's scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

Journal of Clinical and Translational ScienceVol. 9(1)
Meharry Medical College (US), Tufts University (US), Tufts Medical Center (US), Johns Hopkins University (US), Duke University (US), University of Utah (US), Johns Hopkins Medicine (US), Clinical Research Institute (US), Southern California Clinical and Translational Science Institute (US), University of Utah Health Care (US), National Center for Advancing Translational Sciences (US), Vanderbilt University Medical Center (US)
University of Minnesota, University of Kentucky, Johns Hopkins University, Vanderbilt University Medical Center, National Institutes of Health, National Institute on Aging, National Center for Advancing Translational Sciences
Industry, innovation and infrastructure
Openalex Percentile: Top 79%
Health and Medical Research Impacts
DOIOpen Access PDFOpenAlex
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