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 Clinicl Trials (NEXT) aims to conduct multiple, scientifically sound, possibly biomarker informed, exploratory clinical trials ofthe most promising therapies. This proposal outlines the University o Miami's application to serve as a clinical trial site in the NEXT consortium. The experience and expertise of the investigative team at the University of Miami (UM), 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 (62% Hispanic, 20% Black) of the south Florida community, uniquely position the University of Miami 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 NEXT consortium, UM has the capacity and expertise to make a significant contribution to the enrollment of Hispanics and Blacks in NEXT trials, a demographic that has historically been underrepresented in NINDS sponsored trials. The specific goals of the Miami-NEXT team are (a) to function effectively as a NEXT consortium trial site, (b) to enhance quality and efficiency of NEXT and other NINDS trial implementation at the University of Miami and (c) to leverage existing institutional strengths to enhance NEXT consortium activities. Specific components of the research strategy focus on the efficiency of the process of clinical research implementation, the use of a community research associate with knowledge of the community and other 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 clincal trials process and a commitment to provide expertise and assistance to investigators engaged in other NINDS sponsored trials.

Public Health Relevance

A basic tenet of clinical research is that the population studied should reflect that in which the treatment will subsequently be used. Essential, therefore, to the successful development of therapeutics for patients (from every segment of society) with neurological disorders is the inclusion of minority populations in clinical trials. The Universityof Miami is uniquely positioned to contribute the Hispanic demographic to NEXT trials.

National Institute of Health (NIH)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZNS1)
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Cordell, Janice
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University of Miami School of Medicine
Schools of Medicine
Coral Gables
United States
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