CTSDMC awarded $12 million for neurological disease studies

The National Institutes of Health has awarded the Clinical Trials Statistical and Data Management Center (CTSDMC) in the University of Iowa College of Public Health a seven-year, $12 million grant to serve as the Data Coordinating Center for NeuroNext, a national initiative to accelerate the process of turning promising discoveries into new treatments for neurological diseases.

“It is a great honor to be selected as the data coordinating center for this impressive group of institutions,” says Christopher Coffey, Ph.D., UI professor of biostatistics and director of the CTSDMC. “This network provides a new, visionary framework for research on neurological disease, and ultimately will provide faster, better results to those affected populations.”

The objective of the newly created Network for Excellence in Neuroscience Clinical Trials – or NeuroNEXT – is to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. The network is designed to expand the National Institute of Neurological Disorders and Stroke's capability to test promising new therapies, increase the efficiency of clinical trials before embarking on larger studies, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders.

“Funding for rare diseases is hard to come by these days, but we still need answers,” says Coffey. “The NeuroNext network provides the infrastructure – 25 clinical sites across the country, our data coordinating center, and a clinical coordinating center – to allow any researcher the means to find these answers.”

In addition to working as the data coordinating center for the NeuroNext initiative, the UI will also serve as the manufacturer and analytical testing service for drug products prepared for NeuroNext studies through UI Pharmaceuticals (UIP). UIP, a division of the College of Pharmacy, is the largest and most experienced university-affiliated, FDA-registered pharmaceutical manufacturing facility in the United States. In this capacity UIP will work closely with the University of Rochester's Clinical Materials Service Unit CMSU which will provide coordination and drug supply distribution services for this grant. “UIP and CSMU have successfully collaborated to service a number of large clinical trials in recent years,” says Mickey Wells, director of the UIP. “This collaboration is a great example of how university based services can work together to improve disease treatment and mitigation with drug therapies.”