Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials.


Merit Cudkowicz
Marianne K Chase
Christopher S Coffey
Dixie J Ecklund
Brenda J Thornell
Codrin Lungu
Katy Mahoney
Laurie Gutmann
Jeremy M Shefner
Kevin J Staley
Michael Bosch
Eric Foster
Jeffrey D Long
Emine O Bayman
James Torner
Jon Yankey
Richard Peters
Trevis Huff
Robin A Conwit
Shlomo Shinnar
Donna Patch
Basil T Darras
Audrey Ellis
Roger J Packer
Karen S Marder
Claudia A Chiriboga
Claire Henchcliffe
Joyce Ann Moran
Blagovest Nikolov
Stewart A Factor
Carole Seeley
Steven M Greenberg
Anthony A Amato
Sara DeGregorio
Tanya Simuni
Tina Ward
John T Kissel
Stephen J Kolb
Amy Bartlett
Joseph F Quinn
Kellie Keith
Steven R Levine
Nadege Gilles
Patricia K Coyle
Jessica Lamb
Gil I Wolfe
Annemarie Crumlish
Luis Mejico
Muhammad Maaz Iqbal
J D Bowen, Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WashingtonFollow
Caryl Tongco, Swedish Medical Center, Seattle, Washington.Follow
Louis B Nabors
Khurram Bashir
Melanie Benge
Craig M McDonald
Erik K Henricson
Björn Oskarsson
Bruce H Dobkin
Catherine Canamar
Tracy A Glauser
Daniel Woo
Angela Molloy
Peggy Clark
Timothy L Vollmer
Alexander J Stein
Richard J Barohn
Mazen M Dimachkie
Jean-Baptiste Le Pichon
Michael G Benatar
Julie Steele
Lawrence Wechsler
Paula R Clemens
Christine Amity
Robert G Holloway
Christine Annis
Mark P Goldberg
Mariam Andersen
Susan T Iannaccone
A Gordon Smith
J Robinson Singleton
Mariana Doudova
E Clarke Haley
Mark S Quigg
Stephanie Lowenhaupt
Beth A Malow
Karen Adkins
David B Clifford
Mengesha A Teshome
Noreen Connolly

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Publication Date


Publication Title

JAMA Neurol


Importance: One major advantage of developing large, federally funded networks for clinical research in neurology is the ability to have a trial-ready network that can efficiently conduct scientifically rigorous projects to improve the health of people with neurologic disorders.

Observations: National Institute of Neurological Disorders and Stroke Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) was established in 2011 and renewed in 2018 with the goal of being an efficient network to test between 5 and 7 promising new agents in phase II clinical trials. A clinical coordinating center, data coordinating center, and 25 sites were competitively chosen. Common infrastructure was developed to accelerate timelines for clinical trials, including central institutional review board (a first for the National Institute of Neurological Disorders and Stroke), master clinical trial agreements, the use of common data elements, and experienced research sites and coordination centers. During the first 7 years, the network exceeded the goal of conducting 5 to 7 studies, with 9 funded. High interest was evident by receipt of 148 initial applications for potential studies in various neurologic disorders. Across the first 8 studies (the ninth study was funded at end of initial funding period), the central institutional review board approved the initial protocol in a mean (SD) of 59 (21) days, and additional sites were added a mean (SD) of 22 (18) days after submission. The median time from central institutional review board approval to first site activation was 47.5 days (mean, 102.1; range, 1-282) and from first site activation to first participant consent was 27 days (mean, 37.5; range, 0-96). The median time for database readiness was 3.5 months (mean, 4.0; range, 0-8) from funding receipt. In the 4 completed studies, enrollment met or exceeded expectations with 96% overall data accuracy across all sites. Nine peer-reviewed manuscripts were published, and 22 oral presentations or posters and 9 invited presentations were given at regional, national, and international meetings.

Conclusions and Relevance: NeuroNEXT initiated 8 studies, successfully enrolled participants at or ahead of schedule, collected high-quality data, published primary results in high-impact journals, and provided mentorship, expert statistical, and trial management support to several new investigators. Partnerships were successfully created between government, academia, industry, foundations, and patient advocacy groups. Clinical trial consortia can efficiently and successfully address a range of important neurologic research and therapeutic questions.

Clinical Institute

Neurosciences (Brain & Spine)