血液科医师如何保证药物临床试验质量  

How to ensure the quality of drug clinical trials for hematologists

作　　者：王红祥[1] 郭丽银[2] 刘珏[2] 吴耀辉[3] WANG Hongxiang;GUO Liyin;LIU Jue;WU Yaohui(Department of Hematology,Wuhan Central Hospital,Wuhan,430014,China;Clinical Research Ward,Wuhan Central Hospital;Department of Hematology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology)

机构地区：[1]武汉市中心医院血液科,武汉430014 [2]武汉市中心医院临床研究型病房 [3]华中科技大学同济医学院附属协和医院血液科

出　　处：《临床血液学杂志》2023年第1期54-56,共3页Journal of Clinical Hematology

基　　金：2020年湖北省自然科学基金(No:2020CFB790)。

摘　　要：目的:加深血液科临床研究者对《药物临床试验质量管理规范》的认识,确保药物临床试验规范进行。方法:根据核查国内多家中心血液科开展的药物临床试验的经验,结合笔者参加的临床研究,谈谈笔者的体会。结果:从临床试验过程中的每一个环节入手,高度重视临床试验的细节,是药物临床试验顺利完成的关键。结论:血液科的临床试验往往时间较长,需要评价的指标很多,更需要血液科临床研究者认真细致,注重细节,才能保证药物临床试验的质量。Objective:To deepen the understanding of clinical researchers in hematology on the "Good Clinical Practice" and to ensure the standardization of drug clinical trials.Methods:The author’s experience while Verifying drug clinical trials carried out by the hematology departments of several domestic centers was written down,combined with the author’s experience in participating in many clinical trials.Results:Starting from every link in the clinical trial process,paying great attention to details of the clinical trial is the key to the successful completion of drug clinical trials.Conclusion:The period of clinical trials in hematology is often long,there are many indicators that need to be evaluated,and hematologists are required to be more careful and meticulous and should pay attention to details in order to ensure the quality of drug clinical trials.

关 键 词：药物临床试验 血液科 

分 类 号：R733[医药卫生—肿瘤]