T/CACM 022-2017 Chinese Traditional Medicine Real-world Research Technical Specification General Principles

Scope

Main technical content: Real-world research follows the concept of evidence-based medicine. On the basis of accumulating a sufficient number of observational data, it applies methods and techniques such as epidemiology, health statistics, and information science to explore clinical endpoints, quality of life, and health economics indicators of intervention measures in real-world situations, which has become an indispensable important component in the field of clinical evaluation. Since real-world research can conduct long-term evaluations based on patients' actual conditions and treatment preferences, it can evaluate comprehensive effects, adapt to the characteristics of traditional Chinese medicine's holistic concept and differentiated treatment, and is increasingly widely conducted in the field of traditional Chinese medicine. The methods and quality of real-world research are common challenges faced by both traditional Chinese medicine and modern medicine. Based on the characteristics of traditional Chinese medicine real-world research and the actual situation in China, and referring to the international real-world research models, design concepts, and methods, under the guidance of relevant laws and regulations in China, this standard integrates multidisciplinary knowledge to propose technical requirements for conducting real-world research in the real clinical environment of traditional Chinese medicine, with the aim of promoting the improvement of the quality of traditional Chinese medicine real-world research and ensuring the authenticity and scientificity of the research results.

Development Information

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