Towards a Clinical Efficacy Evaluation System Adapted for Personalized Medicine.

The rise of precision medicine (PM) has initiated the transition of mainstream medicine from disease-based medicine to personalized medicine, alongside which the US FDA has begun to establish a clinical trial and efficacy evaluation (CTEE) system compatible with personalized medicine based on biological markers. Outside of modern medicine, however, there has always existed a personalized medical system, traditional Chinese medicine (TCM), that is, a personalized medical system built at the organism level with a similar concept and method to today's complexity science. However, under the current CTEE system, TCM has not usually been shown to be effective. The CTEE system of modern medicine has now begun to embrace personalized medicine at the microlevel. Therefore, there is no reason to continue to reject TCM, which is a type of personalized medicine at the organism level. This paper analyzes and compares the commonality and differences between a personalized medical system based on biomarkers established by PM and a personalized medical system based on syndromes in TCM; the results clearly reveal structural relationships between the two medical systems. On this basis, through rigorous logical reasoning, the feasibility of applying the CTEE method which is used in PM to evaluate the efficacy of TCM treatments is demonstrated. The relationship among biomarkers by which PM describes personalized states and modern medical diseases and the relationship among TCM syndromes and diseases are completely consistent. Because of this consistency, the new CTEE system established by the US FDA to promote the development of PM is fully applicable to the clinical trial and efficacy evaluation of TCM treatment methods. Clinical trials and efficacy evaluations based on this system can scientifically prove the effectiveness of TCM, and TCM is expected to be incorporated into the modern medical system based on scientific norms.