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Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines

The multicenter phase III preclinical trial concept is currently discussed to enhance the predictive value of preclinical stroke research. After public announcement, we collected a community feedback on the concept with emphasis on potential design features and guidelines by an anonymous survey. Res...

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Autores principales: Boltze, Johannes, Wagner, Daniel-Christoph, Henninger, Nils, Plesnila, Nikolaus, Ayata, Cenk
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927600/
https://www.ncbi.nlm.nih.gov/pubmed/27297402
http://dx.doi.org/10.1007/s12975-016-0474-6
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author Boltze, Johannes
Wagner, Daniel-Christoph
Henninger, Nils
Plesnila, Nikolaus
Ayata, Cenk
author_facet Boltze, Johannes
Wagner, Daniel-Christoph
Henninger, Nils
Plesnila, Nikolaus
Ayata, Cenk
author_sort Boltze, Johannes
collection PubMed
description The multicenter phase III preclinical trial concept is currently discussed to enhance the predictive value of preclinical stroke research. After public announcement, we collected a community feedback on the concept with emphasis on potential design features and guidelines by an anonymous survey. Response analysis was conducted after plausibility checks by applying qualitative and quantitative measures. Most respondents supported the concept, including the implementation of a centralized steering committee. Based on received feedback, we suggest careful, stepwise implementation and to leave selected competencies and endpoint analysis at the discretion of participating centers. Strict application of quality assurance methods is accepted, but should be harmonized. However, received responses also indicate that the application of particular quality assurance models may require more attention throughout the community. Interestingly, clear and pragmatic preferences were given regarding publication and financing, suggesting the establishing of writing committees similar to large-scale clinical trials and global funding resources for financial support. The broad acceptance among research community encourages phase III preclinical trial implementation. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12975-016-0474-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-49276002016-07-13 Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines Boltze, Johannes Wagner, Daniel-Christoph Henninger, Nils Plesnila, Nikolaus Ayata, Cenk Transl Stroke Res SI: Challenges and Controversies in Translational Stroke Research The multicenter phase III preclinical trial concept is currently discussed to enhance the predictive value of preclinical stroke research. After public announcement, we collected a community feedback on the concept with emphasis on potential design features and guidelines by an anonymous survey. Response analysis was conducted after plausibility checks by applying qualitative and quantitative measures. Most respondents supported the concept, including the implementation of a centralized steering committee. Based on received feedback, we suggest careful, stepwise implementation and to leave selected competencies and endpoint analysis at the discretion of participating centers. Strict application of quality assurance methods is accepted, but should be harmonized. However, received responses also indicate that the application of particular quality assurance models may require more attention throughout the community. Interestingly, clear and pragmatic preferences were given regarding publication and financing, suggesting the establishing of writing committees similar to large-scale clinical trials and global funding resources for financial support. The broad acceptance among research community encourages phase III preclinical trial implementation. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12975-016-0474-6) contains supplementary material, which is available to authorized users. Springer US 2016-06-14 2016 /pmc/articles/PMC4927600/ /pubmed/27297402 http://dx.doi.org/10.1007/s12975-016-0474-6 Text en © The Author(s) 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle SI: Challenges and Controversies in Translational Stroke Research
Boltze, Johannes
Wagner, Daniel-Christoph
Henninger, Nils
Plesnila, Nikolaus
Ayata, Cenk
Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
title Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
title_full Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
title_fullStr Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
title_full_unstemmed Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
title_short Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
title_sort phase iii preclinical trials in translational stroke research: community response on framework and guidelines
topic SI: Challenges and Controversies in Translational Stroke Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927600/
https://www.ncbi.nlm.nih.gov/pubmed/27297402
http://dx.doi.org/10.1007/s12975-016-0474-6
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