The key elements on the clinical trail design of traditional Chinese medicine from the perspective of clinical value
Traditional Chinese medicine(TCM)plays an important role in ensuring the health of the people,and its efficacy is a core reflection of its clinical value and significance.A scientific,detailed,and clear clinical trial protocol is of great significance for accurately assessing the clinical efficacy of drugs,which can fully reflect their clinical value,ensure the scientific,reliable,and accurate nature of clinical trials,and ultimately guarantee their successful completion.This article followed the design principles of clinical trial protocols,combined with the rich experience accumulated by our team in long-term clinical trial practice.From the perspective of how to reflect the clinical value of drugs,the determination of the purpose and the clinical positioning of the drug clinical trials,the selection of participants and the controls,the setting of corresponding statistical boundary values for clinical trial were discussed.And the selection of clinical efficacy outcomes which could reflect the clinical value and clinical significance of the drugs,the key design elements of clinical trial protocols-"PICOS"principle were comprehensively and deeply analyzed and discussed,aiming to provide a scientific,reasonable,and practical reference for the design of TCM clinical trial protocols that emphasize clinical value.
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