The Duke University/Vanderbilt University Trial Innovation Center
The Duke/Vanderbilt Trial Innovation Center provides consultation and research solutions to investigators who are collaborating with the Trial Innovation Network on multicenter clinical trials and studies. Partnerships include access to the resources and expertise of more than 60 medical research institutions, including the Duke Clinical and Translational Science Institute. Together, we’re committed to improving the quality and cost of clinical research so we can bring more treatments to more patients in less time.
For more information about the Trial Innovation Network and proposal submission, visit https://trialinnovationnetwork.org.
|Budget||Data Coordinating Center|
|Recruitment & Retention||Standard contract agreements|
|Feasibility||Recruitment plan and feasibility assessment|
|Grant submission||Recruitment materials|
|Electronic Health Record–based cohort assessment|
How the Trial Innovation Network Advances Clinical Research
Learn how the Trial Innovation Network can help you conduct better, faster, more cost-efficient trials to improve patient care.
Trials and studies
We support a broad range of clinical research, including trials across the human life span; trials for diagnostic testing or development of therapeutics such as drugs, biologics, and devices; registry studies; and behavioral interventions. Our Trial Innovation Center will connect you with experts in your subject, methodology, and study population.
We’re currently supporting more than 25 studies, from consultation to implementation. Here are three of the studies in progress:
- An initial consultation for an RO1 application to perform gene sequencing on endophthalmitis samples and identify genetic factors associated with this severe eye infection.
- A comprehensive consultation for a Phase II application to study the safety of Sildenafil in premature infants with severe bronchopulmonary dysplasia, a chronic lung disease.
- Implementation of a study comparing the effectiveness of different blood-thinner medications in the long-term prevention of recurrent blood clots.
STRESS Trial Shows Value of Trial Innovation Network
The drug methylprednisolone is a steroid that has been prescribed since 1955 to help reduce inflammation after heart surgery, including in pediatric patients. Children, especially infants, process drugs differently than adults do. However, the use of this drug in children has never been studied, because it’s ethically and logistically difficult to include children in clinical trials.
Drs. Kevin Hill and Jennifer Li, pediatric cardiologists at Duke Children’s Hospital, received funding from the National Institutes of Health to conduct the first large-scale study of the drug in infants: the STeroids to REduce Systemic Inflammation After Neonatal Heart Surgery (STRESS) trial. To meet their recruitment goal of 1,200 participants, they would need to work with more than 25 institutions. Securing IRB approval and signed contracts for all of the different sites presented a giant logistical hurdle.
“The Trial Innovation Center took charge of all of that for us. They helped coordinate all materials for sites and guided us through the Central IRB process,” Dr. Hill said. “Those steps would have required a massive learning curve and effort on our part, which would have delayed the process. By taking that off our plate, it freed us up to concentrate on working with our fellow investigators to educate and enroll participants.”
Operational excellence, innovation, and collaboration
The Duke Clinical Research Institute and Vanderbilt University Medical Center work together to provide high-quality operational support for Trial Innovation Network clinical trials. Our joint center consists of four teams: Study Design, Study Start-Up, Study Conduct, and Innovations.
Daniel K. Benjamin Jr., MD, PhD, MPH
Associate Faculty Director, Duke Clinical Research Institute
Kiser-Arena Distinguished Professor of Pediatrics
Principal Investigator and Chair of the National Institute of Child Health and Human Development’s Pediatric Trials Network
Gordon R. Bernard, MD
Melinda Owen Bass Professor of Medicine Associate Vice-Chancellor for Research
Senior Associate Dean for Clinical Science
Chairman, Pharmacy and Therapeutics Committee
The Duke/Vanderbilt Trial Innovation Center is funded by the National Center for Advancing Translational Sciences (grant 1U24TR001608-01), part of the National Institutes of Health, and is a partner of the Trial Innovation Network.