my country’s first "Technical Guidelines for the Real World Research of Chinese Patent Medicines" has been issued and implemented

On October 25, 2021, the National Group Information Platform released the "Technical Guidelines for the Real World Research of Chinese Patent Medicines" (T/CATCM011—2021) , which was drafted by the China Association of Chinese Materia Medica and other organizations.
"Principles" group standards are to ensure the standardization of real-world research on Chinese patent medicines, which will help researchers to conduct research in a standardized, reasonable and scientific manner, promote the production and use of real-world evidence of high-quality Chinese patent medicines in China, and strongly promote the Chinese patent medicine industry.
Development, conforming to international standards and adapting to China's national conditions and characteristics of Chinese patent medicines, has filled up the gaps in the real-world research field of Chinese patent medicines in China
.

The "Guiding Principles for the Real World Research Technology of Chinese Patent Medicines" (T/CATCM011—2021) drafted by organizations such as China Association of Chinese Materia Medica

1.
Standard information of "Guiding Principles for Real World Research Technology of Chinese Patent Medicines"

1.
Standard information of "Guiding Principles for Real World Research Technology of Chinese Patent Medicines"

2.
The background of the formulation of the "Guiding Principles for Real-World Research Technologies of Chinese Patent Medicines"

2.
The background of the formulation of the "Guiding Principles for Real-World Research Technologies of Chinese Patent Medicines"

Real-world research is the hot spot of current clinical evaluation
.

On February 12, 2018, the China Association of Chinese Materia Medica issued the "Guiding Principles for the Real World Research Technology of Chinese Patent Medicines" Group Standard Project Announcement (Guo Zhong Ma Xie [2018] No.

First,

Second, form the real-world data resources of Chinese patent medicines, build a real-world research database of Chinese patent medicines and regional medical data resources of Chinese patent medicines ;third , carry out empirical research on the clinical evaluation and supervision of Chinese patent medicines, focusing on the clinical evaluation and post-marketing monitoring of Chinese patent medicines Evaluation, selection of proprietary Chinese patent medicines with medical advantages, integrating RCT, systematic reviews, real-world data and research technology, carrying out empirical research, promoting the transformation of decision-making, and solving industry pain points;fourth, establishing an exchange mechanism with domestic and foreign academic organizations, Interact with the China Real World Data and Research Alliance to promote academic exchanges
.

On October 11-12, 2019, sponsored by China Association of Chinese Materia Medica, China Center for Evidence-Based Medicine, and co-organized by Tianjin University of Traditional Chinese Medicine Center for Evidence-Based Medicine and other units, "China Association of Chinese Materia Medica Real World Research Professional Committee Founding Conference and Chinese Medicine Real World Research Academic The seminar" was successfully held in Beijing

Second, third, fourth,

3.
Introduction to the main contents of "Guiding Principles of Real-World Research Technology for Chinese Patent Medicines"

3.
Introduction to the main contents of "Guiding Principles of Real-World Research Technology for Chinese Patent Medicines"

The real-world research of proprietary Chinese medicines refers to researches based on the specific research issues of proprietary Chinese medicines, integrated information science, epidemiology, statistics, economics and other multidisciplinary methods and technologies, based on real-world data
.

In essence, real-world research on proprietary Chinese medicines is a research method, not a specific research program
.

According to data sources, common real-world research on proprietary Chinese medicines includes research based on routinely collected data, research based on patient registration data, and observational research and practical clinical trials based on the real-world data framework system.

The main chapters of "Guiding Principles of Real World Research Technology for Chinese Patent Medicines" aim at various common real-world research methods, including research topics, method selection, data collection, data processing, statistical analysis, economic evaluation, etc.

References [1] [2]ebm.