CTSDMC NeuroNEXT Team
About NeuroNEXT
The Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry.
Funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS), NeuroNEXT was designed to:
- Increase efficiency of clinical trials
- Expand the capability of NINDS to test promising new therapies
- Respond quickly as opportunities arise to test promising new treatments for people with neurological disorders
The NeuroNEXT Network consists of a Clinical Coordinating Center (CCC) at Massachusetts General Hospital, a Data Coordinating Center (DCC) at the University of Iowa, with clinical sites throughout the country. Since 2011, we have been working together to improve productivity and expedite therapy development for neurological disorders. Features of the Network, including a single IRB and a standardized Master Trial Agreement, are designed to efficiently conduct Phase II Clinical Trials. Studies in the Network are expected to take advantage of the experienced CCC and DCC, who work with investigators through the life-cycle of their project, as well as the well-trained clinical sites located throughout the US. Our funding comes from the National Institute of Neurological Disorders and Stroke (NINDS), and we work closely with NINDS representatives in all of our undertakings.
Meet the NeuroNEXT CCC CO-PIs
Merit Cudkowicz, MD, MSc
Dr. Cudkowicz is currently the Chief of Neurology, Director of the Sean M. Healey & AMG Center for ALS, Neurologist, and Director of the Neurological Clinical Research Institute at Massachusetts General Hospital. She is also the Julieanne Dorn Professor of Neurology at Harvard Medical School and Co-Founder and past Co-Chair of the Northeast ALS Consortium.
Aleksandar Videnovic, MD
Dr. Videnovic is currently Clinician Investigator in the Neurological Clinical Research Institute at the Massachusetts General Research Institute, and a Neurologist at Massachusetts General Hospital. He is also the Chief of the Division of Sleep Neurology at Partners HealthCare in Massachusetts General Brigham, and a Professor of Neurology at Harvard Medical School.
The CTSDMC 's Role as DCC
The NeuroNEXT DCC provides statistical leadership from trial design and implementation, to final analysis and publication. The DCC experts on the Statistical Design Team assist investigators in developing innovative methodologies for the design and analysis of clinical trials. The Statistical Implementation Team, on the other hand, provides day-to-day statistical support for ongoing trials.
As part of our efforts to provide a web-based distributed data entry system with the capability to quickly, efficiently, and accurately randomize subjects and collect data generated by Network studies, the NeuroNEXT DCC provides full data management and information technology support from conception and planning to execution and close-out of each Network project. The Data Management Team and the IT/Development Team work closely together to develop, test, validate and bring into production user-friendly electronic data capture systems with robust data security features.
In conjunction with the Clinical Coordinating Center, the DCC provides integrated protocol coordination support for all Network projects. The DCC Protocol Coordination and Monitoring team interacts nearly daily with the clinical sites to promote, monitor, review, query, and finalize data collection for each Network project.