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Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines

机译:中风研究的三期临床前试验:社区对框架和指南的回应

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摘要

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.Electronic supplementary materialThe online version of this article (doi:10.1007/s12975-016-0474-6) contains supplementary material, which is available to authorized users.
机译:目前正在讨论多中心III期临床前试验概念,以提高临床前中风研究的预测价值。公开发布后,我们通过匿名调查收集了有关该概念的社区反馈,重点是潜在的设计功能和指南。在进行合理性检查后,通过定性和定量措施进行了反应分析。大多数答复者都支持这一概念,包括实施集中指导委员会。根据收到的反馈,我们建议谨慎,分步实施,并由参与中心自行决定是否保留选定的能力和终点分析。严格应用质量保证方法已被接受,但应加以协调。但是,收到的答复还表明,特定质量保证模型的应用可能需要整个社区给予更多关注。有趣的是,在出版和经费筹措方面存在明显和务实的偏好,这建议建立类似于大型临床试验和全球资金支持的写作委员会。研究界的广泛接受鼓励III期临床前试验的实施。电子补充材料本文的在线版本(doi:10.1007 / s12975-016-0474-6)包含补充材料,授权用户可以使用。

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