Advances and challenges in preclinical evaluation of therapeutic drugs for treating ischemic stroke
10.16438/j.0513-4870.2016-1018
- VernacularTitle:缺血性卒中药物临床前研究的挑战及其对策
- Author:
Ying PENG
1
;
Fei MA
1
;
Ting-ting XU
1
;
Shan WANG
1
;
Long-jian HUANG
1
;
Xiao-ying WANG
2
;
Yong-jun WANG
3
;
Xiao-liang WANG
1
Author Information
1. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China
2. Massachusetts General Hospital, Harvard Medical School, Boston 02129, USA
3. Beijing Tian Tan Hospital, Capital Medical University, Beijing 100050, China
- Publication Type:PROFESSIONALS FORUM
- Keywords:
ischemic stroke;
therapeutic drug;
preclinical research;
clinical translation
- From:
Acta Pharmaceutica Sinica
2017;52(3):339-346
- CountryChina
- Language:Chinese
-
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 involved:animal 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.
