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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

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Fulltext (PDF; )

Translational Stroke Research 7 (2016), No.4, pp.241-247
ISSN: 1868-4483
ISSN: 1868-601X
English
Journal Article, Electronic Publication
Fraunhofer IZI ()
Fraunhofer EMB ()
Animal models; focal ischemia; randomized controlled trials; multicenter preclinical trials; regeneration and recovery

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.

: http://publica.fraunhofer.de/documents/N-399895.html