Journal of Clinical and Translational Science (Jan 2025)
Insights from the trial innovation network’s initial consultation process
- Paul A. Harris,
- Nan Kennedy,
- Consuelo H. Wilkins,
- Karen Lane,
- Gordon R. Bernard,
- Jonathan D. Casey,
- Daniel E. Ford,
- Salina P. Waddy,
- Ken L. Wiley,
- Terri L. Edwards,
- Nichol McBee,
- Dixie D. Thompson,
- Mary Stroud,
- Emily S. Serdoz,
- Sarah J. Nelson,
- Michelle Jones,
- Lindsay M. Eyzaguirre,
- Leslie R. Boone,
- Jessica Baird,
- Colleen E. Lawrence,
- Elizabeth Holthouse,
- Sarah K. Cook,
- Maeve Tischbein,
- Natalya Amrine,
- Tiffany Chen,
- Jodie Cohen,
- LaShondra Deyampert,
- Natalie A. Dilts,
- Delicia Burts,
- Amna Baig,
- Joseph G. Christodoulou,
- Mariela Rodriguez,
- Edgar R. Miller,
- James F. Casella,
- W. Andrew Mould,
- J. Michael Dean,
- Daniel K. Benjamin,
- Harry P. Selker,
- Marisha E. Palm,
- Lori Poole,
- Jeri S. Burr,
- Sara Hassani,
- Angeline Nanni,
- Meghan Hildreth,
- Daniel F. Hanley
Affiliations
- Paul A. Harris
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA
- Nan Kennedy
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Consuelo H. Wilkins
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Department of Internal Medicine, Meharry Medical College, Nashville, TN, USA.
- Karen Lane
- ORCiD
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Gordon R. Bernard
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
- Jonathan D. Casey
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
- Daniel E. Ford
- ORCiD
- Johns Hopkins University School of Medicine, Baltimore, MD, USA Johns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA
- Salina P. Waddy
- National Center for Advancing Translational Sciences, Bethesda, MD, USA
- Ken L. Wiley
- National Center for Advancing Translational Sciences, Bethesda, MD, USA
- Terri L. Edwards
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Nichol McBee
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Dixie D. Thompson
- University of Utah Health, Salt Lake City, UT, USA Utah Clinical & Translational Science Institute, Salt Lake City, UT, USA
- Mary Stroud
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Emily S. Serdoz
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Sarah J. Nelson
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Michelle Jones
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Lindsay M. Eyzaguirre
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Leslie R. Boone
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Jessica Baird
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Colleen E. Lawrence
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Elizabeth Holthouse
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Sarah K. Cook
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Maeve Tischbein
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Natalya Amrine
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Tiffany Chen
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Jodie Cohen
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- LaShondra Deyampert
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Natalie A. Dilts
- ORCiD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Delicia Burts
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Amna Baig
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Joseph G. Christodoulou
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Mariela Rodriguez
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
- Edgar R. Miller
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- James F. Casella
- Johns Hopkins University School of Medicine, Baltimore, MD, USA Johns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA
- W. Andrew Mould
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- J. Michael Dean
- University of Utah Health, Salt Lake City, UT, USA
- Daniel K. Benjamin
- Duke University School of Medicine, Durham, North Carolina, USA
- Harry P. Selker
- ORCiD
- Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA
- Marisha E. Palm
- ORCiD
- Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA
- Lori Poole
- Duke Clinical Research Institute, Durham, NC, USA
- Jeri S. Burr
- University of Utah Health, Salt Lake City, UT, USA
- Sara Hassani
- National Center for Advancing Translational Sciences, Bethesda, MD, USA
- Angeline Nanni
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Meghan Hildreth
- Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Daniel F. Hanley
- ORCiD
- Johns Hopkins University School of Medicine, Baltimore, MD, USA Johns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA
- DOI
- https://doi.org/10.1017/cts.2025.10084
- Journal volume & issue
-
Vol. 9
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.
Keywords
- Multicenter studies
- Trial Innovation Network
- Trial Innovation Center
- Recruitment Innovation Center
- scientific consultation
