HAN Mei, WANG Yuyi, LI Qing, et al. Development of Statistical Analysis Plan in Clinical Trials in Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2014, 55(15): 1280-1283.
HAN Mei, WANG Yuyi, LI Qing, et al. Development of Statistical Analysis Plan in Clinical Trials in Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2014, 55(15): 1280-1283.DOI: 10.13288/j.11-2166/r.2014.15.006.
Development of Statistical Analysis Plan in Clinical Trials in Traditional Chinese Medicine
statistical analysis plan is necessary for full utilization of data and reasonableness and reliability of clinical results. There are many problems in statistical analysis of TCM clinical trials such as missing or incomplete statistical analysis plan
lack of statistical methods
unclear description or improper selection of statistical methods and mismatched comparison type and testing purpose. In order to solve the above problems
statistical analysis plan should be developed according to the characteristics of TCM clinical research such as determining comparison type according to the purpose of trial and establishing assumption based on the primary and secondary outcomes of intervention and the outcome evaluation. Furthermore
statistical analysis plan should include a brief description of clinical trial and the determination of sample size
statistical power
statistical methods and statistical analysis dataset.
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Related Author
ZHANG Ying
WANG Liqiong
FEI Yutong
LI Xun
HAN Mei
ZHANG Xiatian
HU Yeyin
LIU Jianping
Related Institution
School of Traditional Chinese Medicine, Beijing University of Chinese Medicine
School of AcupunctureMoxibustion and Tuina,Beijing University of Chinese Medicine