Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Cudkowicz Merit, Chase Marianne K, Coffey Christopher S, Ecklund Dixie J, Thornell Brenda J, Lungu Codrin, Mahoney Katy, Gutmann Laurie, Shefner Jeremy M, Staley Kevin J, Bosch Michael, Foster Eric, Long Jeffrey D, Bayman Emine O, Torner James, Yankey Jon, Peters Richard, Huff Trevis, Conwit Robin A, NeuroNEXT Clinical Study Sites, Shinnar Shlomo, Patch Donna, Darras Basil T, Ellis Audrey, Packer Roger J, Marder Karen S, Chiriboga Claudia A, Henchcliffe Claire, Moran Joyce Ann, Nikolov Blagovest, Factor Stewart A, Seeley Carole, Greenberg Steven M, Amato Anthony A, DeGregorio Sara, Simuni Tanya, Ward Tina, Kissel John T, Kolb Stephen J, Bartlett Amy, Quinn Joseph F, Keith Kellie, Levine Steven R, Gilles Nadege, Coyle Patricia K, Lamb Jessica, Wolfe Gil I, Crumlish Annemarie, Mejico Luis, Iqbal Muhammad Maaz, Bowen James D, Tongco Caryl, Nabors Louis B, Bashir Khurram, Benge Melanie, McDonald Craig M, Henricson Erik K, Oskarsson Björn, Dobkin Bruce H, Canamar Catherine, Glauser Tracy A, Woo Daniel, Molloy Angela, Clark Peggy, Vollmer Timothy L, Stein Alexander J, Barohn Richard J, Dimachkie Mazen M, Le Pichon Jean-Baptiste, Benatar Michael G, Steele Julie, Wechsler Lawrence, Clemens Paula R, Amity Christine, Holloway Robert G, Annis Christine, Goldberg Mark P, Andersen Mariam, Iannaccone Susan T, Smith A Gordon, Singleton J Robinson, Doudova Mariana, Haley E Clarke, Quigg Mark S, Lowenhaupt Stephanie, Malow Beth A, Adkins Karen, Clifford David B, Teshome Mengesha A, Connolly Noreen
Аннотация
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.