The online version of this article (doi:10.1007/s12975-016-0474-6) contains supplementary material, which is available to authorized users.
Nikolaus Plesnila and Cenk Ayata contributed equally to this work.
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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Boltze J, Ayata C,Wagner DC, Plesnila N. Preclinical phase III trials in translational stroke research: call for collective design of framework and guidelines. Stroke. 2014;45(2):357.
Boltze J, Wagner DC, Barthel H, Gounis MJ. Academic-industry collaboration in translational stroke research. Trans Stroke Res. 2016. doi: 10.1007/s12975-016-0475-5
- Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines
- Springer US