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

Autor:	Cudkowicz M; Massachusetts General Hospital, Boston., Chase MK; Massachusetts General Hospital, Boston., Coffey CS; The University of Iowa, Iowa City., Ecklund DJ; The University of Iowa, Iowa City., Thornell BJ; Massachusetts General Hospital, Boston., Lungu C; Division of Clinical Research, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, Maryland., Mahoney K; Massachusetts General Hospital, Boston., Gutmann L; The University of Iowa, Iowa City., Shefner JM; Barrow Neurological Institute, University of Arizona College of Medicine, Tucson., Staley KJ; Massachusetts General Hospital, Boston., Bosch M; The University of Iowa, Iowa City., Foster E; The University of Iowa, Iowa City., Long JD; The University of Iowa, Iowa City., Bayman EO; The University of Iowa, Iowa City., Torner J; The University of Iowa, Iowa City., Yankey J; The University of Iowa, Iowa City., Peters R; The University of Iowa, Iowa City., Huff T; The University of Iowa, Iowa City., Conwit RA; Division of Clinical Research, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, Maryland., Shinnar S; Montefiore Medical Center: Einstein Campus, Bronx, New York., Patch D; Montefiore Medical Center: Einstein Campus, Bronx, New York., Darras BT; Boston Children's Hospital, Boston, Massachusetts., Ellis A; Boston Children's Hospital, Boston, Massachusetts., Packer RJ; Children's National Hospital, Washington, DC., Marder KS; Columbia University Irving Medical Center, New York, New York.; Weill Cornell Medical, New York, New York., Chiriboga CA; Columbia University Irving Medical Center, New York, New York.; Weill Cornell Medical, New York, New York., Henchcliffe C; Columbia University Irving Medical Center, New York, New York.; Weill Cornell Medical, New York, New York., Moran JA; Columbia University Irving Medical Center, New York, New York.; Weill Cornell Medical, New York, New York., Nikolov B; Columbia University Irving Medical Center, New York, New York.; Weill Cornell Medical, New York, New York., Factor SA; Emory University School of Medicine, Atlanta, Georgia., Seeley C; Emory University School of Medicine, Atlanta, Georgia., Greenberg SM; Massachusetts General Hospital, Boston.; Brigham and Women's Hospital, Boston, Massachusetts., Amato AA; Massachusetts General Hospital, Boston.; Brigham and Women's Hospital, Boston, Massachusetts., DeGregorio S; Massachusetts General Hospital, Boston.; Brigham and Women's Hospital, Boston, Massachusetts., Simuni T; Northwestern University Feinberg School of Medicine, Chicago, Illinois., Ward T; Northwestern University Feinberg School of Medicine, Chicago, Illinois., Kissel JT; Ohio State University Wexner Medical Center, Columbus., Kolb SJ; Ohio State University Wexner Medical Center, Columbus., Bartlett A; Ohio State University Wexner Medical Center, Columbus., Quinn JF; Oregon Health & Science University, Portland., Keith K; Oregon Health & Science University, Portland., Levine SR; SUNY Downstate Medical Center, Brooklyn, New York., Gilles N; SUNY Downstate Medical Center, Brooklyn, New York., Coyle PK; Stony Brook University, State University of New York, Stony Brook., Lamb J; Stony Brook University, State University of New York, Stony Brook., Wolfe GI; University at Buffalo, State University of New York, Buffalo., Crumlish A; University at Buffalo, State University of New York, Buffalo., Mejico L; SUNY Upstate Medical University, Syracuse, New York., Iqbal MM; SUNY Upstate Medical University, Syracuse, New York., Bowen JD; Swedish Medical Center, Seattle, Washington., Tongco C; Swedish Medical Center, Seattle, Washington., Nabors LB; University of Alabama at Birmingham, Birmingham., Bashir K; University of Alabama at Birmingham, Birmingham., Benge M; University of Alabama at Birmingham, Birmingham., McDonald CM; Univeristy of California, Davis, Davis., Henricson EK; Univeristy of California, Davis, Davis., Oskarsson B; Univeristy of California, Davis, Davis., Dobkin BH; University of California, Los Angeles, Los Angeles., Canamar C; University of California, Los Angeles, Los Angeles., Glauser TA; Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio., Woo D; Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio., Molloy A; Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio., Clark P; Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio., Vollmer TL; University of Colorado, Aurora., Stein AJ; University of Colorado, Aurora., Barohn RJ; Children's Mercy Hospital, University of Kansas, Kansas City, Missouri., Dimachkie MM; Children's Mercy Hospital, University of Kansas, Kansas City, Missouri., Le Pichon JB; Children's Mercy Hospital, University of Kansas, Kansas City, Missouri., Benatar MG; University of Miami Miller School of Medicine, Coral Gables, Florida., Steele J; University of Miami Miller School of Medicine, Coral Gables, Florida., Wechsler L; University of Pittsburgh, Pittsburgh, Pennsylvania., Clemens PR; University of Pittsburgh, Pittsburgh, Pennsylvania., Amity C; University of Pittsburgh, Pittsburgh, Pennsylvania., Holloway RG; University of Rochester, Rochester, New York., Annis C; University of Rochester, Rochester, New York., Goldberg MP; UT Southwestern Medical Center, Dallas, Texas., Andersen M; UT Southwestern Medical Center, Dallas, Texas., Iannaccone ST; UT Southwestern Medical Center, Dallas, Texas., Smith AG; University of Utah, Salt Lake City., Singleton JR; University of Utah, Salt Lake City., Doudova M; University of Utah, Salt Lake City., Haley EC; University of Virginia, Charlottesville., Quigg MS; University of Virginia, Charlottesville., Lowenhaupt S; University of Virginia, Charlottesville., Malow BA; Vanderbilt University, Nashville, Tennessee., Adkins K; Vanderbilt University, Nashville, Tennessee., Clifford DB; Washington University, St Louis, Missouri., Teshome MA; Washington University, St Louis, Missouri., Connolly N; University of Rochester, Rochester, New York.
Jazyk:	angličtina
Zdroj:	JAMA neurology [JAMA Neurol] 2020 Jun 01; Vol. 77 (6), pp. 755-763.
DOI:	10.1001/jamaneurol.2020.0367
Abstrakt:	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.
Databáze:	MEDLINE
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