Zobrazeno 1 - 10
of 247
pro vyhledávání: '"Master protocol"'
Autor:
Madhavi Gidh-Jain, Tom Parke, Franz König, Cecile Spiertz, Peter Mesenbrink, On behalf of EU-PEARL (Europe [EU] Patient-cEntric clinicAl tRial pLatforms) an Innovative Medicines Initiative (IMI) initiative Work Package 2 (WP 2)
Publikováno v:
Trials, Vol 25, Iss 1, Pp 1-12 (2024)
Abstract Background Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice—scientific g
Externí odkaz:
https://doaj.org/article/41034feb6c904b84bbff4537bf0f0790
Publikováno v:
Xiehe Yixue Zazhi, Vol 15, Iss 5, Pp 1157-1164 (2024)
Adaptive design, with advantages such as dynamically adjusting trial plans, reducing resource waste, and improving trial efficiency, has broken through the competitive situation of new drug development and gradually met the needs of clinical research
Externí odkaz:
https://doaj.org/article/f7ef88732498479eb03aa9c95879b123
Autor:
Courtney Barnes, Jannah Jones, Luke Wolfenden, Katie Robertson, Anna Lene Seidler, Jennifer Norman, Pip Budgen, Megan Mattingly, Carla Piliskic, Lisa Moorhouse, Jennifer Mozina, Jennifer Plaskett, Sarah McDermott, Sara Darney, Cecilia Vuong, Nina Douglass, Kara McDonnell, Rachel Sutherland
Publikováno v:
Frontiers in Public Health, Vol 12 (2024)
IntroductionAn important impediment to the large-scale adoption of evidence-based school nutrition interventions is the lack of evidence on effective strategies to implement them. This paper describes the protocol for a “Collaborative Network Trial
Externí odkaz:
https://doaj.org/article/122858920eaa4580ab400f39b5d3d293
Autor:
Stacey J. Adam, Timothy G. Buchman, Judith S. Currier, Ruxandra Draghia-Akli, Josh P. Fessel, Elizabeth S. Higgs, Eric A. Hughes, Lisa LaVange, Joseph P. Menetski, Sarah W. Read, Yves Rosenberg, Randall Tressler, ACTIV Therapeutics-Clinical Working Group
Publikováno v:
Journal of Clinical and Translational Science, Vol 8 (2024)
The Accelerating COVID-19 Therapeutic Interventions and Vaccines Therapeutic-Clinical Working Group members gathered critical recommendations in follow-up to lessons learned manuscripts released earlier in the COVID-19 pandemic. Lessons around agent
Externí odkaz:
https://doaj.org/article/a7c8b5fb4a0045bfa8f5cc35ccb6d74c
Autor:
Maryam Keshtkar-Jahromi, Stacey J. Adam, Indira Brar, Lucy K. Chung, Judith S. Currier, Eric S. Daar, Victoria J. Davey, Eileen T. Denning, Annetine C. Gelijns, Elizabeth S. Higgs, Prasanna Jagannathan, Arzhang Cyrus Javan, Tomas O. Jensen, Nikolaus Jilg, Ioannis Kalomenidis, Peter Kim, Seema U. Nayak, Matthew Newell, Babafemi O. Taiwo, Tammy Yokum, Yvette Delph
Publikováno v:
Journal of Clinical and Translational Science, Vol 8 (2024)
The United States Government (USG) public-private partnership “Accelerating COVID-19 Treatment Interventions and Vaccines” (ACTIV) was launched to identify safe, effective therapeutics to treat patients with Coronavirus Disease 2019 (COVID-19) an
Externí odkaz:
https://doaj.org/article/b429d74352644bba8ed889493a0a3109
Publikováno v:
Current Oncology, Vol 30, Iss 4, Pp 3964-3973 (2023)
A platform trial is a trial involving an innovative adaptive design with a single master protocol to efficiently evaluate multiple interventions. It offers flexible features such as dropping interventions for futility and adding new interventions to
Externí odkaz:
https://doaj.org/article/33fdd38bef8f4634b329a51404cc2481
Akademický článek
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Akademický článek
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Autor:
David B. Dunger, Sylvaine F. A. Bruggraber, Adrian P. Mander, M. Loredana Marcovecchio, Timothy Tree, Piotr Jaroslaw Chmura, Mikael Knip, Anke M. Schulte, Chantal Mathieu, on behalf of the INNODIA consortium
Publikováno v:
Trials, Vol 23, Iss 1, Pp 1-9 (2022)
Abstract Background The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of cli
Externí odkaz:
https://doaj.org/article/579881137eaa49e583e9b682b21fba96
Publikováno v:
Frontiers in Medicine, Vol 9 (2022)
BackgroundThe efficiencies that master protocol designs can bring to modern drug development have seen their increased utilization in oncology. Growing interest has also resulted in their consideration in non-oncology settings. Umbrella trials are on
Externí odkaz:
https://doaj.org/article/4f32537c19ed4c039cff2d46a8280884