The development of new therapeutics for patients with neurological disorders, which critically hinges on the efficiency of clinical trials, may be greatly facilitated by clinical trials consortia. The Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) aims to conduct multiple; scientifically sound, possibly biomarker informed, exploratory clinical trials of the most promising therapies. This proposal outlines the University of Miami's application to serve as a clinical trial site in the NeuroNEXT consortium, in partnership with Nemours Children's Hospital for pediatric studies. The experience and expertise of the investigative team at the University of Miami (UM) and Nemours, the commitment, infrastructure and investment of the Department of Neurology and the School of Medicine in clinical and translational research, and the ethnic and racial diversity (66% Hispanic, 19% Black) of the south Florida community, uniquely position us to contribute to the mission of NINDS to reduce the burden of neurological disease that is borne by every segment of society. In addition to serving as an efficient and productive member of the NeuroNEXT consortium, we have the capacity and expertise to make a significant contribution to the enrollment of Hispanics and Blacks in NeuroNEXT trials, a demographic that has historically been underrepresented in NINDS sponsored trials. The specific goals of our NeuroNEXT team are to continue service as an effective site in the NeuroNEXT network, leveraging our unique strengths and expertise for the benefit of the broader network; and to continue development our clinical-translational workforce, providing young investigators and research staff with educational, training and career growth opportunities. Specific components of the research strategy focus on the efficiency of the process of clinical research implementation, the use of a culturally sensitive approaches to recruitment of the Hispanic population, education and training of new clinical investigators, recognition of the pivotal role that research coordinators play in the clinical trials process and a commitment to provide expertise and assistance to investigators engaged in other NINDS sponsored trials.

Public Health Relevance

The University of Miami Department of Neurology, in partnership with the Division of Neurology in the Department of Pediatrics at Nemours Children's Hospital, will continue its service as a clinical trial in the NeuroNEXT network, contributing high quality data from a diverse population of both adult and pediatric patients with a range of neurological diseases.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24NS107376-03
Application #
9980517
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Cordell, Janice
Project Start
2018-07-01
Project End
2023-06-30
Budget Start
2020-07-01
Budget End
2021-06-30
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Miami School of Medicine
Department
Neurology
Type
Schools of Medicine
DUNS #
052780918
City
Coral Gables
State
FL
Country
United States
Zip Code
33146