【摘要】 新药研发的高质量发展是全民健康的重要保障。近年来，我国的新药研发发展方兴未艾，新药临床试验的发展日新月异。Ⅰ期临床试验研究作为新药研发的重要组成部分，对新药的安全性和药物代谢动力学研究具有重要价值。传统的Ⅰ期临床试验病区管理模式在医疗管理相关制度流程、急救保障体系、质量管理体系、医生团队综合能力、护理团队临床实践能力等方面尚待完善，如何构建高质量发展的Ⅰ期临床试验管理体系和运行模式是当前亟需面对的挑战和问题。本研究结合我院Ⅰ期新药临床试验病区运行经验，提出“多学科诊疗模式的Ⅰ期新药临床试验病区”运行模式概念，倡导多专业领域的研究医师、研究护士团队与研究药师共同组建高质量的多学科诊疗模式研究团队，把控新药Ⅰ期临床试验的各个关键核心环节，确保对新药毒副反应与疗效的科学评价，保障新药药物代谢动力学研究的精准，维护患者的利益与安全。本研究认为，“多学科诊疗模式的Ⅰ期新药临床试验病区”目前虽仍在探索阶段，必将为新药Ⅰ期临床研究的高质量发展注入强劲动力。更多还原

【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.更多还原