NeuroNEXT

Benefits of Partnering with NeuroNEXT for Academic Researchers

The NeuroNEXT Network is designed to efficiently conduct Phase II Clinical Trials. We accomplish this goal by bringing together 25 experienced, well-trained clinical sites across the US. Chosen for their expertise and geographical location, this Network allows us to target an expanded patient population for every project. Additionally, each site has agreed to a Master Clinical Trial Agreement, which serves as a one-time contract for participation in NeuroNEXT projects, and the use of a single, centralized Institutional Review Board (IRB). These features allow us to overcome the two greatest hurdles for multi-site clinical trials: acquiring a signed contract and individual site IRB approval. 

Our Network also includes the Clinical Coordinating Center (CCC) at MGH and the Data Coordinating Center (DCC) at the University of Iowa. The coordinating centers assist in project development for proposed studies and project management of funded studies. The CCC and DCC have worked collaboratively to develop a variety of resources to support the Network, including Standard Operating Procedures, grant development guidance, and several systems to enhance data collection, regulatory controls and safety management.

Some key ways that NeuroNEXT has maximized the operational efficiency of clinical trials includes:

• Use of a Central IRB, which decreases the average time for full protocol approval – currently 64 days for the Network
• The DCC’s efficient EDC development – which includes the use of Common Data Elements, five core database modules, and eight core Case Report Forms – has reduced the average time from funding announcement to database release to 3.6 months (compared to 8.6 months for non-network studies)
• The electronic Trial Master File system allows sites to upload all required regulatory documents, increasing efficiency in document review and approval and streamlining the document storage. The Network has uploaded and reviewed over 21,000 documents for over 1,300 site personnel involved in our current studies!
• Enrollment in NeuroNEXT studies has exceeded norms within disease-specific clinical trials. We attribute our rapid study recruitment to our ability to share best practices in recruitment within and between sites; the hard work of our Recruitment, Retention & Diversity Committee to evaluate and advise investigators and study teams; and our close evaluation of screening data to determine trends and amend inclusion/exclusion criteria as needed for better study recruitment
• High quality data, with 96% data accuracy Network-wide (defined as the percentage of CRFs that required no changes)
• Network infrastructure that allows innovations in trial designs, including futility designs, CRM, and Bayesian outcome models. The Network is a leader in adaptive trial designs. 
• The use of NIH Shared Resources, including NIH Toolbox for validated surveys and outcome measures to aid in trial design; Common Data Elements to increase the utility of standardized data sets for sharing with the scientific community; use of the Recruitment Planning and Monitoring System to allow for monitoring of trends across sites, studies and disease states; and collaboration with other NINDS-funded Networks to share best practices on clinical trial operations 

To get started with a NeuroNEXT application, please visit our grant application page.