Department of Neurology
Nervous System Diseases | Neurology | Translational Medical 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.
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Citation: Transl Stroke Res. 2016 Jun 14. doi:10.1007/s12975-016-0474-6 [Epub ahead of print]. Link to article on publisher's website. 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.
Animal models, Experimental, Focal ischemia, Multicenter preclinical trials, Randomized controlled trials, Regeneration and recovery
Boltze, Johannes; Wagner, Daniel-Christoph; Henninger, Nils; Plesnila, Nikolaus; and Ayata, Cenk, "Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines" (2016). Neurology Publications and Presentations. 453.
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This work is licensed under a Creative Commons Attribution 4.0 License.