摘要
目的:随着国家对新药临床试验核查要求的提高,建立一支专业化的新药临床试验研究团队和形成一套完善的管理模式,成为提高新药临床评价质量的有效途径。本文结合近些年泌尿外科专业组的工作经验逐渐摸索形成了一个"5P-3L"新药临床试验创新管理模式,制定了一套较为完善的培训体系,从人员管理、培训、奖励机制等各个方面加强人才培养和团队建设,最终提高新药临床试验研究水平。
With the improvement of national requirements for the examination and verification of new drug clinical trials,the establishment of a specialized clinical trial research team and the perfect management mode have become effective ways to effectively improve the quality of clinical evaluation of new drugs.Based on the work experience in recent years in urology,we has gradually formed an innovative "5 P-3 L" management model for the new drugs clinical trial,and formulated a relatively complete training system.We will strengthen personnel training and team building in personnel management,training and reward mechanisms,and eventually raise the level of research on new drugs in clinical trials.
作者
礼嵩
唐守艳
周铁
盛夏
LI Song;TANG Shou-yan;ZHOU Tie;SHENG Xia(Department of Urology,Changhai Hospital,The Second Military Medical University,National Good Clinical Practice Center For Novel Drugs of Tumor and Diseases of Genitourinary System,Shanghai 200433,China)
出处
《中国医院药学杂志》
CAS
北大核心
2020年第12期1380-1384,共5页
Chinese Journal of Hospital Pharmacy
基金
国家科技部“重大新药创新”专项课题(编号:2017ZX09304030)
海军军医大学第一附属医院教育研究课题资助项目(编号:CHJG2019034)。
关键词
新药临床试验
管理模式
团队建设
培训
new clinical trials
management mode
team building
training
