Journal article
Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials
JAMA neurology, Vol.77(6), pp.755-763
06/01/2020
DOI: 10.1001/jamaneurol.2020.0367
PMCID: PMC7483960
PMID: 32202612
Abstract
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.
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.
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.
Details
- Title: Subtitle
- Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials
- Creators
- Merit Cudkowicz - Massachusetts General Hospital, BostonMarianne K Chase - Massachusetts General Hospital, BostonChristopher S Coffey - The University of Iowa, Iowa CityDixie J Ecklund - The University of Iowa, Iowa CityBrenda J Thornell - Massachusetts General Hospital, BostonCodrin Lungu - Division of Clinical Research, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MarylandKaty Mahoney - Massachusetts General Hospital, BostonLaurie Gutmann - The University of Iowa, Iowa CityJeremy M Shefner - Barrow Neurological Institute, University of Arizona College of Medicine, TucsonKevin J Staley - Massachusetts General Hospital, BostonMichael Bosch - The University of Iowa, Iowa CityEric Foster - The University of Iowa, Iowa CityJeffrey D Long - The University of Iowa, Iowa CityEmine O Bayman - The University of Iowa, Iowa CityJames Torner - The University of Iowa, Iowa CityJon Yankey - The University of Iowa, Iowa CityRichard Peters - The University of Iowa, Iowa CityTrevis Huff - The University of Iowa, Iowa CityRobin A Conwit - Division of Clinical Research, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MarylandShlomo Shinnar - Montefiore Medical Center: Einstein Campus, Bronx, New YorkDonna Patch - Montefiore Medical Center: Einstein Campus, Bronx, New YorkBasil T Darras - Boston Children's Hospital, Boston, MassachusettsAudrey Ellis - Boston Children's Hospital, Boston, MassachusettsRoger J Packer - Children's National Hospital, Washington, DCKaren S Marder - Weill Cornell Medical, New York, New YorkClaudia A Chiriboga - Weill Cornell Medical, New York, New YorkClaire Henchcliffe - Weill Cornell Medical, New York, New YorkJoyce Ann Moran - Weill Cornell Medical, New York, New YorkBlagovest Nikolov - Weill Cornell Medical, New York, New YorkStewart A Factor - Emory University School of Medicine, Atlanta, GeorgiaCarole Seeley - Emory University School of Medicine, Atlanta, GeorgiaSteven M Greenberg - Brigham and Women's Hospital, Boston, MassachusettsAnthony A Amato - Brigham and Women's Hospital, Boston, MassachusettsSara DeGregorio - Brigham and Women's Hospital, Boston, MassachusettsTanya Simuni - Northwestern University Feinberg School of Medicine, Chicago, IllinoisTina Ward - Northwestern University Feinberg School of Medicine, Chicago, IllinoisJohn T Kissel - Ohio State University Wexner Medical Center, ColumbusStephen J Kolb - Ohio State University Wexner Medical Center, ColumbusAmy Bartlett - Ohio State University Wexner Medical Center, ColumbusJoseph F Quinn - Oregon Health & Science University, PortlandKellie Keith - Oregon Health & Science University, PortlandSteven R Levine - SUNY Downstate Medical Center, Brooklyn, New YorkNadege Gilles - SUNY Downstate Medical Center, Brooklyn, New YorkPatricia K Coyle - Stony Brook University, State University of New York, Stony BrookJessica Lamb - Stony Brook University, State University of New York, Stony BrookGil I Wolfe - University at Buffalo, State University of New York, BuffaloAnnemarie Crumlish - University at Buffalo, State University of New York, BuffaloLuis Mejico - SUNY Upstate Medical University, Syracuse, New YorkMuhammad Maaz Iqbal - SUNY Upstate Medical University, Syracuse, New YorkJames D Bowen - Swedish Medical Center, Seattle, WashingtonCaryl Tongco - Swedish Medical Center, Seattle, WashingtonLouis B Nabors - University of Alabama at Birmingham, BirminghamKhurram Bashir - University of Alabama at Birmingham, BirminghamMelanie Benge - University of Alabama at Birmingham, BirminghamCraig M McDonald - Univeristy of California, Davis, DavisErik K Henricson - Univeristy of California, Davis, DavisBjörn Oskarsson - Univeristy of California, Davis, DavisBruce H Dobkin - University of California, Los Angeles, Los AngelesCatherine Canamar - University of California, Los Angeles, Los AngelesTracy A Glauser - Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OhioDaniel Woo - Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OhioAngela Molloy - Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OhioPeggy Clark - Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OhioTimothy L Vollmer - University of Colorado, AuroraAlexander J Stein - University of Colorado, AuroraRichard J Barohn - Children's Mercy Hospital, University of Kansas, Kansas City, MissouriMazen M Dimachkie - Children's Mercy Hospital, University of Kansas, Kansas City, MissouriJean-Baptiste Le Pichon - Children's Mercy Hospital, University of Kansas, Kansas City, MissouriMichael G Benatar - University of Miami Miller School of Medicine, Coral Gables, FloridaJulie Steele - University of Miami Miller School of Medicine, Coral Gables, FloridaLawrence Wechsler - University of Pittsburgh, Pittsburgh, PennsylvaniaPaula R Clemens - University of Pittsburgh, Pittsburgh, PennsylvaniaChristine Amity - University of Pittsburgh, Pittsburgh, PennsylvaniaRobert G Holloway - University of Rochester, Rochester, New YorkChristine Annis - University of Rochester, Rochester, New YorkMark P Goldberg - UT Southwestern Medical Center, Dallas, TexasMariam Andersen - UT Southwestern Medical Center, Dallas, TexasSusan T Iannaccone - UT Southwestern Medical Center, Dallas, TexasA Gordon Smith - University of Utah, Salt Lake CityJ Robinson Singleton - University of Utah, Salt Lake CityMariana Doudova - University of Utah, Salt Lake CityE Clarke Haley - University of Virginia, CharlottesvilleMark S Quigg - University of Virginia, CharlottesvilleStephanie Lowenhaupt - University of Virginia, CharlottesvilleBeth A Malow - Vanderbilt University, Nashville, TennesseeKaren Adkins - Vanderbilt University, Nashville, TennesseeDavid B Clifford - Washington University, St Louis, MissouriMengesha A Teshome - Washington University, St Louis, MissouriNoreen Connolly - University of Rochester, Rochester, New YorkNeuroNEXT Clinical Study Sites
- Resource Type
- Journal article
- Publication Details
- JAMA neurology, Vol.77(6), pp.755-763
- DOI
- 10.1001/jamaneurol.2020.0367
- PMID
- 32202612
- PMCID
- PMC7483960
- NLM abbreviation
- JAMA Neurol
- ISSN
- 2168-6149
- eISSN
- 2168-6157
- Grant note
- U24 NS107165 / NINDS NIH HHS U10 NS077265 / NINDS NIH HHS U01 NS077352 / NINDS NIH HHS U24 NS107182 / NINDS NIH HHS U01 NS077179 / NINDS NIH HHS U24 NS107181 / NINDS NIH HHS P50 HD103537 / NICHD NIH HHS U24 NS107166 / NINDS NIH HHS U10 NS077323 / NINDS NIH HHS U24 NS107128 / NINDS NIH HHS U24 NS107205 / NINDS NIH HHS
- Language
- English
- Date published
- 06/01/2020
- Academic Unit
- Neurology; Psychiatry; Epidemiology; Biostatistics; Surgery; Anesthesia; College of Public Health; Injury Prevention Research Center; Neurosurgery
- Record Identifier
- 9984214672802771
Metrics
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