Necessity,principle and procedures of clinical trials optimization in TCM / 中华中医药杂志

ABSTRACT

Optimization of Traditional Chinese Medicine (TCM) clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.