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

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

SUBMITTER: Boltze J 

PROVIDER: S-EPMC4927600 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature