While effective treatments have been developed for some neurological disorders, there is room for improvement in existing treatments and a desperate need for treatments for diseases where none exist. Because of the extraordinary progress in basic neuroscience, we expect that the next decade will transform the opportunity to develop and test new therapies. Scientists are unraveling molecular, cellular and circuit functions of the nervous system and are identifying genes and pathways that cause disease. Imaging techniques allow scientists and physicians to examine the living human brain in exquisite detail. These new insights will fuel the development of new treatments that will need to be tested in patients.
Clinical trials are an essential step in determining if and how new drugs, biologics or devices might benefit patients. Having an effective and efficient system for conducting clinical trials is critical to realizing the promise of basic and translational neuroscience. Our experience and the experience of others indicate that the time and cost of clinical trials decrease when trial networks are used.
To address the opportunities and need for testing new therapies, NINDS has established the Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT. The network was created with three main goals in mind. First, we want to support scientifically valid, biomarker-informed Phase 2 (exploratory) clinical trials so that we can efficiently test new treatments before embarking on large and costly Phase 3 (efficacy) trials. Second, we want to expand our ability to test the most promising new therapies, whether from academic or industry investigators. Third, as trial opportunities arise for a wide range of disorders affecting both children and adults, we want to provide the infrastructure for and expertise of a cadre of disease-specific investigators.
Through NeuroNEXT, the NINDS is supporting 25 clinical sites across the United States, together with two other components: a clinical coordinating center to provide cost-effective management in operating multiple trials, and a data coordinating center that will provide state-of-the-art efficient statistical designs and take advantage of the economy of scales in data management and quality control, as well as set the stage for the sharing and mining of the valuable clinical datasets generated from the many research projects funded by the NINDS. One particularly innovative aspect of NeuroNEXT is the use of a common IRB that should significantly decrease the time between trial design and initiation while ensuring patient safety.
We anticipate that the network will not only help testing promising treatments for people with neurological disorders, but will also provide jobs across the US, will enable pharmaceutical companies to conduct trials efficiently in the US, and will stimulate growth in US biomedical research through public private partnerships.
Last updated November 17, 2011