Review: The First Seven Years of NeuroNEXT

In 2011, the National Institute of Neurological Disorders and Stroke (NINDS) established the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). Its charge was to expedite development of new therapies across neurologic diseases by improving the quality and efficiency of multicenter clinical trials.

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In JAMA Neurology, Merit Cudkowicz, MD, MSc, chief of the Department of Neurology at Massachusetts General Hospital, and colleagues describe the structure of NeuroNEXT and its accomplishments in its first seven years.

Structure

NeuroNEXT comprises:

• A clinical coordinating center (CCC) — central institutional review board, central pharmacy and central laboratory
• A data coordinating center (DCC)
• 25 clinical sites

These are overseen by an executive committee and its subcommittees, a data and safety monitoring board and an external scientific advisory board, all directed by NINDS.

The network's initial charge was to secure funding for five to seven trials. It exceeded that goal, as nine trials were funded through NeuroNEXT grant mechanisms. This review reports preaward and postaward data on eight trials. Three of the nine funded principal investigators had not previously led a multicenter study.

Preaward Results

Experienced investigators in the CCC and DCC helped 25 investigators, including 12 who were writing a National Institutes of Health grant for the first time, to submit initial grant applications. One grant was funded after initial review and 14 investigators responded to critiques of their initial application. Seven of those applications were eventually funded.

Median intervals were 10 months from proposal submission to initial grant submission, 19 months from initial proposal to grant resubmission and 27.5 months from initial proposal to funding.

Postaward Results

The greatest challenges during the initiation of the network were to establish a central institutional review board (IRB) and the master clinical trial agreement. Once they were acceptable to all institutions, these advances had substantial positive effects on study start-up. The central IRB decreased the time required to add sites to a trial once the first site was approved. The master agreement eliminated the need for contract negotiation, bringing the time for contract execution to 0 for all trials.

Across the first eight trials, protocols were approved in an average of 59 days after submission to the central IRB and sites were approved in an average of 22 days. The median time from approval to first site activation was 47.5 days and the median time from first site activation to first participant consent was 27 days.

Enrollment and Retention

A subcommittee of the executive committee advised investigators on recruitment techniques for each disease population and assisted with retention. In the first four trials that completed data analysis of the primary outcome, enrollment met or exceeded norms for trials within the same disease state. Notably, the trial in multiple sclerosis and the trial in myasthenia gravis enrolled about twice as fast as expected.

The average retention rate across all studies was high at 89%.

What's NEXT

In 2018, NeuroNEXT was renewed for another five years. Education and training of future trialists has already been initiated with a formal training course and webinars. In the renewal period there will also be opportunities for collaboration with broader networks, including the Clinical and Translational Science Awards Program and disease foundations, to partner on the most exciting targets and treatments.

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