The National Institutes of Health (NIH) has renewed Vanderbilt University Medical Center’s (VUMC) membership in NeuroNEXT, a research network that helps streamline Phase 2 clinical trials for brain disorders.
VUMC, which first joined the network in 2012, is among 25 sites chosen for participation over the next five years. Beth Malow, M.D., M.S., Burry Professor of Cognitive Childhood Development, professor of Neurology and Pediatrics, vice-chair of clinical research for Neurology, and a Vanderbilt Kennedy Center investigator, is a network principal investigator who co-chairs two network committees.
“Membership in a major NIH clinical trial consortium, such as NeuroNEXT, contributes greatly to the clinical science, the quality of patient care, and the prestige of the institution,” said Gordon Bernard, M.D., Executive Vice President for Research and the Melinda Owen Bass Professor of Medicine.
“Receipt of such an award indicates VUMC and Dr. Malow are among the best in the nation when it comes to the conduct of clinical research in neurological syndromes.”
NeuroNEXT was started in 2012 to make neuroscience clinical trials more efficient and to help increase the number of treatments that get into clinical practice.
The program is designed to encourage collaborations among academic centers, disease foundations, and industry. If a researcher is considering a Phase 2 clinical study but does not have the experience to conduct it, he or she can apply to the NeuroNEXT program to leverage the resources that are available at the participating centers.
For example, NeuroNEXT centers can provide equipment, standardize data acquisition and analysis, or help with patient recruitment. In addition, since each study takes place simultaneously in several different clinical centers, it takes less time to enroll the targeted number of patients than would be the case with a single center study.
“We are very honored and grateful to be renewed as a site and to have the opportunity to continue to participate in this exciting network,” Malow said.
Malow’s NeuroNEXT co-investigators at VUMC include David Charles, M.D., professor and vice chair of Neurology; Amanda Peltier, M.D., associate professor of Neurology; and Lori Jordan, M.D., Ph.D., associate professor of Pediatrics. The streamlined protocols within the network make it easier to recruit participants for studies and to get those studies started, she said.
“A unique feature is that we have a centralized institutional review board [IRB] so that we don’t have a situation where multiple sites are trying to get their IRB applications submitted and approved. It makes the IRB process a lot smoother.”
Malow serves as co-chair of the Education Committee, which this round has received approval to support training of young investigators in clinical trials, and as co-chair of the Pipeline Committee, which assists medical companies with clinical trials.
“One of our goals is to increase the education of our trainees in neurology and neurological disease,” Malow said. “This round will support a NeuroNEXT fellow who will work side by side with our investigators to understand trials, how they work, and how they are conducted.”
The National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, supports NeuroNEXT.
“One of the advantages of NeuroNEXT, and something that makes it unique, is the network’s ability to quickly mobilize a group of specialists from a certain disease area to initiate a clinical study when opportunities emerge for trials,” said Robin Conwit, M.D., program director at NINDS. “The structure of NeuroNEXT, with its broad focus across neuroscience clinical studies, has the potential to reach many individuals who are affected by brain disorders.”
A total of nine clinical trials currently in various stages have been implemented within the NeuroNEXT, said Codrin Lungu, M.D., the NINDS program director.
“We are thrilled to continue working with the sites that have been participating in the network, and we look forward to collaborating with the eight sites that will be joining the program,” Lungu said.
Tom Wilemon is an information officer in Vanderbilt University Medical Center News & Communications. This article was first published in VUMC Reporter, July 26, 2018.