This project falls within the field of clinical medicine in traditional Chinese medicine (TCM) and the scope of clinical translational research. Clinical trials are an important means to verify the efficacy and safety of TCM, but for a long time, the methodology of TCM clinical trials has been backward, with most still based on traditional models, low management efficiency, poor data quality, and difficulty in meeting the standards for international mutual recognition of data; secondly, the design methods for TCM clinical trials are single-minded, have low adaptability, high failure rates, cannot meet the requirements for precise trial protocol design, and lack individualized efficacy analysis techniques for TCM clinical syndrome modifications. In view of this, this project adopts networked, standardized, and quantitative technologies, combined with the characteristics and needs of TCM, after decades of effort, has created, improved, and integrated a series of innovative achievements: 1. Pioneered the establishment of a new model for the network implementation of TCM clinical trials: First to adopt pharmaceutical identification code technology, pharmaceutical dosage warning technology, The investigational drug is integrated with random number separation technology, timestamping technology, and electronic data collection techniques to form an integrated application platform. It has been applied in 264 clinical trials, of which 127 have obtained new drug certificates, such as Guanxinning tablets, Danshen polyphenolic acid for injection, Jingyin granules, etc. At the same time, the project team used this model to provide technical support for the clinical trial of Fuzheng Huayu tablets in the United States, achieving high-quality research results. 2. Pioneered the establishment of a new quantitative design mode for traditional Chinese medicine (TCM) clinical trial protocols: By using quantitative pharmacology techniques, namely modeling, simulation, and prediction technologies, to provide a basis for the design of trial protocols, various methods were created, improved, and integrated to form a quantitative design system, including: (1) Model-based meta-analysis, which established the first standard efficacy scale, confirming the effectiveness of plant estrogens (TCM) in treating menopausal syndrome in women. Corrected the conclusions of a study published in The Lancet; (2) Based on clinical pharmacokinetics and pharmacodynamics combined model technology, for the first time used to precisely select safe and effective doses of traditional Chinese medicine, discovered the therapeutic dose of 1.1 new drug tripterygium glycosides for the treatment of rheumatoid arthritis, which is more toxic. In addition, the clinical trial design of traditional Chinese medicine rhizoma polygonati glycosides was recognized and approved by the U.S. FDA for implementation; (3) Based on clinical physiological pharmacokinetics model technology, for the first time directly used animal data from traditional Chinese medicine for bridging and prediction, providing a basis for the formulation of the first human trial protocol for the antitussive effect of 1.1 new drug naringin. The individual conversion formula between effective doses in humans and animals was cited 768 times. 3. Established the first key technology for personalized efficacy analysis in clinical practice with traditional Chinese medicine: created a design method of 'limiting flavors, selecting drugs according to syndrome differentiation, adding and subtracting according to symptoms, and adjustable dosage', as well as various data analysis models and algorithms. Through clinical trials, optimizing formulas, and deriving new ones, a design model for the screening of clinical traditional Chinese medicine compound prescriptions has been formed, which can guide individualized prescription medication. The project team used this technology to successfully screen out traditional Chinese medicine formulations for lowering blood sugar and obtained verification. This project: (1) Published a total of 144 papers, including 39 SCI-indexed papers with a total impact factor of 114 points, positively cited 2376 times by others, and with 86 SCI citations. (2) Obtained 23 software copyrights, 6 invention patents, and 6 clinical approval documents for new drugs from formula screening. (3) Presented reports at more than 80 domestic and international academic conferences, including 3 keynote presentations; trained 29 graduate students and 3 postdoctoral fellows; won first place in the International Quantitative Pharmacology Modeling Competition twice and second place once. (4) Undertook 8 national continuing education projects, serving a total of over 2000 people. (5) The project's achievements have been incorporated into 21 textbooks or monographs; the principal investigator participated in writing one international clinical trial guideline, six national food and drug administration-related guidelines, and six expert consensus documents. (6) The application of the project's technology has exceeded 840 institutions, covering more than 30 provinces and cities across the country (including Hong Kong and Taiwan), with academic citations reaching 17,900 times. The project has made significant technical breakthroughs in multiple aspects, providing methodological foundations for the modernization and internationalization of traditional Chinese medicine clinical trials, and offering strong technical support for the improvement of the quality and efficiency of TCM clinical trials.