关键词: 新药研发, Ⅰ期临床试验, 多学科诊疗模式, 患者安全, 药代动力学

Abstract:

 The high-quality development of new drug research and development serves as a critical safeguard for public health. In recent years， China has achieved significant progress in new drug development， and drug clinical trials are evolving rapidly. Phase I clinical trials， as an integral part of new drug research and development， hold substantial value for the safety assessment and pharmacokinetic studies of new drugs.The traditional mode of Phase I clinical trial ward still needs to be improved in the aspects of medical management protocols， emergency response system， quality management systems，the comprehensive capabilities of the physician teams and the clinical practice skills of nursing teams.Therefore， constructing a high-quality management system and operational mode for Phase I clinical trials is a challenge and issue that need to be faced. This study， based on the operation experience from the Phase I clinical trial ward of our hospital， proposes the concept of "Phase I clinical trial ward with multidisciplinary diagnosis and treatment mode"，which advocates for the formation of a high-quality Multidisciplinary Team （MDT） research group， comprising physicians， nurses， and pharmacists from various specialties， to control the key core links of new drug Phase I clinical trials. It ensures the scientific evaluation of new drug side effects and efficacy， guarantees the precision of new drug pharmacokinetic research， and safeguards the interests and safety of patients.This study posits that， although the" Phase I clinical trial ward with multidisciplinary diagnosis and treatment mode" is still in the exploration stage， it will significantly enhance the high-quality development of phase I clinical research of new drugs.

Key words:  , New drug research and development；Phase I clinical trials； Multidisciplinary diagnosis and treatment mode； Patient safety；Pharmacokinetics