Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines.
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.
Fraunhofer Research Institution for Marine Biotechnology and Institute for Medical and Marine Biotechnology, University of Lübeck, Mönkhofer Weg 239a, 23562, Lübeck, Germany. johannes.boltze@emb.fraunhofer.de.|Fraunhofer Institutes for Cell Therapy and Immunology, Leipzig, Germany. johannes.boltze@emb.fraunhofer.de.
Johannes
J
Boltze
Fraunhofer Institutes for Cell Therapy and Immunology, Leipzig, Germany.
Daniel-Christoph
DC
Wagner
Department of Neurology, University of Massachusetts Medical School, Worcester, MA, USA.
Nils
N
Henninger
Institute for Stroke and Dementia Research, University of Munich Medical Center, Munich, Germany.
Nikolaus
N
Plesnila
Neurovascular Research Lab, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Cenk
C
Ayata
D017326:Clinical Trials, Phase III as Topic / Q000191:economics / Q000379:methods* / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D012107:Research Design / Q000592:standards* / Q000639:trends; D012111:Residence Characteristics; D020521:Stroke / Q000628:therapy*; D011795:Surveys and Questionnaires; D057170:Translational Research, Biomedical
Animal models; Experimental; Focal ischemia; Multicenter preclinical trials; Randomized controlled trials; Regeneration and recovery