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Advances and challenges in preclinical evaluation of therapeutic drugs for treating ischemic stroke / 药学学报
Acta Pharmaceutica Sinica ; (12): 339-346, 2017.
Article in Chinese | WPRIM | ID: wpr-779598
ABSTRACT
Translating of scientific advances into clinical practice is a major challenge in the stroke research field in the past decades. There were many reasons involvedanimal models might not accurately capture all aspects of clinical stroke in humans, the blind and randomized design principle was not closely followed, the inclusion and exclusion criteria was not previously established, sample size was inadequate, endpoint was not scientific nor blindly assessed, inadequate reporting of data and statistical flaws. To bridge the gap between experimental and clinical research, international consortia have attempted to establish standardized guidelines for study design and data report, which include optimizing animal models as well as experimental design, using innovative approaches to assess endpoint, making raw data and negative results available, establishing prior registration mechanism, conducting multicenter preclinical randomized controlled trials (pRCTs), systematic reviews and meta-analysis of preclinical studies, evolving the original focus on neuroprotection into a broader consideration of the role of neurovascular unit and ischemic cascade.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial / Practice guideline / Prognostic study Language: Chinese Journal: Acta Pharmaceutica Sinica Year: 2017 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial / Practice guideline / Prognostic study Language: Chinese Journal: Acta Pharmaceutica Sinica Year: 2017 Type: Article