Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
UMass Chan Affiliations
Department of NeurologyDocument Type
Journal ArticlePublication Date
2016-06-14Keywords
Animal modelsExperimental
Focal ischemia
Multicenter preclinical trials
Randomized controlled trials
Regeneration and recovery
Nervous System Diseases
Neurology
Translational Medical Research
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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.Source
Transl Stroke Res. 2016 Jun 14. doi:10.1007/s12975-016-0474-6 [Epub ahead of print]. Link to article on publisher's website.DOI
10.1007/s12975-016-0474-6Permanent Link to this Item
http://hdl.handle.net/20.500.14038/37773PubMed ID
27297402Notes
Co-author Nils Henninger is a doctoral student in the Millennium PhD Program (MPP) in the Graduate School of Biomedical Sciences (GSBS) at UMass Medical School.
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Copyright © 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.Distribution License
http://creativecommons.org/licenses/by/4.0/ae974a485f413a2113503eed53cd6c53
10.1007/s12975-016-0474-6
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Except where otherwise noted, this item's license is described as Copyright © 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.