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    Home > Active Ingredient News > Drugs Articles > The clinical evaluation methods of drugs will be changed, which will promote the approval and listing of traditional Chinese medicine

    The clinical evaluation methods of drugs will be changed, which will promote the approval and listing of traditional Chinese medicine

    • Last Update: 2020-01-09
    • Source: Internet
    • Author: User
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    [pharmaceutical network industry trends 】On January 7, the State Drug Administration issued the notice on the guiding principles of real world evidence supporting drug research and development and evaluation (Trial) Currently, "randomized controlled trials" widely used in drug clinical research institutes are in urgent need of new drug clinical evaluation methods due to the limitations of limited safety information, uncertain extrapolation of efficacy conclusion, lack of economic benefits, etc Law to complement and improve The "real world research" mentioned in the circular is a new methodology for clinical evaluation of drugs This methodology was proposed by the United States of America and has been widely concerned in recent years to evaluate the effectiveness and safety of drugs It is understood that real world research is based on the use of real world data, through the collection of innovative technology and the actual effect data of drugs in clinical use, to help medical decision makers understand the real effect and safety they can play in different medical environments Its characteristics are objective, scientific and real, and the real curative effect of reducing drugs in clinical application is compared According to the guiding principles, the real world evidence has six application areas, including the famous traditional Chinese medicine empirical formula, the human experience summary and clinical research and development of traditional Chinese medicine medical institution preparation, etc Industry insiders pointed out that real world research is closely related to the development of traditional Chinese medicine industry, which has also been paying attention to real world research Due to the lack of evaluation system in line with the characteristics of traditional Chinese medicine, traditional Chinese medicine has been facing difficulties in the process of approval and listing, and it is difficult to promote to the world However, real world evidence can accelerate the clinical research of new Chinese medicine registration, or help those traditional Chinese Medicine with guaranteed effectiveness and safety to pass the approval and listing However, how to collect a large number of clinical cases that meet the requirements of the research scheme is a big problem for the TCM industry to carry out real world research, and the industry is also exploring this aspect It is reported that the new China pharmaceutical industry, together with the real world research professional committee of the World Federation of Chinese Medicine Societies, has created a new tripartite cooperation mode of "in hospital + out hospital", breaking through this dilemma At present, it has cooperated with a number of large hospitals to collect cases and obtain hospital data In recent years, the research of real world evidence in China has been accelerating In May 2019, the drug review center of China drug administration released the basic consideration of real world evidence supporting drug research and development (Draft for comments), which is equivalent to policy guarantee for domestic pharmaceutical enterprises In this context, many pharmaceutical companies are concerned about the real world evidence For example, Boji medicine pointed out in the semi annual report 2019 that the draft pointed out that using real world evidence to evaluate the effectiveness and safety of drugs has become a possible strategy and path This opinion aims to support drug research and development, clarify the definition of real world research in drug research and development, clarify the status and application scope of real world evidence in drug research and development, explore the evaluation principles of real world evidence, and provide scientific and feasible guidance for industry to use real world evidence to support drug research and development At present, it is generally believed that the release of the guiding principles will provide policy guarantee for the application of real world research in TCM and other fields In addition, in addition to benefiting the traditional Chinese medicine industry, real world research can also boost the development of new indications for new drugs and the actual effect of patients in the real world.
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