The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, has awarded the 10-year contract to Duke to design, manage, and conduct Phase I clinical trials. The trials will be conducted at the Duke Clinical Research Unit (DCRU), the early-phase clinical trial unit of the Duke Clinical Research Institute. The DCRU’s state-of-the-art 40-bed study and observation facility is one of a small number of academic early phase research units in the country.
Support for the contract will be provided as part of the NIH Blueprint for Neuroscience Research Neurotherapeutics Network. The goal of the network is to speed the transition of promising new therapies from the lab to the clinic by supporting early stages of research and then working with industry to get treatments to patients.
“This award reinforces Duke’s position as a leader in early-phase trials,” said Andrew Krystal, M.D., director of the Neurosciences Medicine Research Program at the Duke Clinical Research Institute, who will serve as the principal investigator for the trials. “It’s an opportunity for faculty across multiple disciplines to contribute, and for Duke to be engaged at the ground level in the development of new treatments for neurological disorders.”
The full-service Phase I Clinical Trial Unit for Neurotherapeutics will evaluate new compounds or therapies that intervene on a molecular level, including small molecules, peptides, proteins and oligonucleotides.
Most of the trials will assess the rate of drug absorption into the body as well as the time it takes for drug elimination. The studies will also evaluate drug safety in people and help identify maximum tolerated dosages. In some cases, patients with neurological conditions may be included, but most early trials will test drugs in healthy people. The study is supported by the National Institute of Neurological Disorders and Stroke (HHSN271201600004I). ###
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