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Phase III preclinical trials in translational stroke research : community response on framework and guidelines
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Boltze, Johannes, Wagner, Daniel-Christoph, Henninger, Nils, Plesnila, Nikolaus and Ayata, Cenk (2016) Phase III preclinical trials in translational stroke research : community response on framework and guidelines. Translational Stroke Research, 7 (4). pp. 241-247. doi:10.1007/s12975-016-0474-6 ISSN 1868-4483.
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Official URL: http://dx.doi.org/10.1007/s12975-016-0474-6
Abstract
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.
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Divisions: | Faculty of Science, Engineering and Medicine > Science > Life Sciences (2010- ) | ||||||
| Journal or Publication Title: | Translational Stroke Research | ||||||
| Publisher: | Springer | ||||||
| ISSN: | 1868-4483 | ||||||
| Official Date: | August 2016 | ||||||
| Dates: |
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| Volume: | 7 | ||||||
| Number: | 4 | ||||||
| Page Range: | pp. 241-247 | ||||||
| DOI: | 10.1007/s12975-016-0474-6 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) |
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