摘要
抗肿瘤药物的临床试验一般选择肿瘤患者作为受试者。由于肿瘤患者通常伴有复杂的全身疾病状态,对研究者准确判断临床试验期间不良事件造成困扰。本文从研究医生的角度出发,探讨通过参与试验方案的设计,全员培训统一的不良事件判断规则,以及采取多学科协作的方式,对抗肿瘤药物临床试验中的不良事件进行规范化判断,从而提高抗肿瘤药物临床试验的质量。
The clinical trials of anti-tumor drugs generally select tumor patients as subjects. Due to the complexity of systemic disease status of tumor patients,it is difficult for investigators to accurately judge the adverse events during the clinical trials. This article from the perspective of the study doctor, discuss how to conduct standardized judgment of adverse events in anti-tumor drugs clinical trials,by participating in design the protocol of clinical trials,implementing employee training to unify the rules of judgment of the adverse events and using a multiple disciplinary team approach,in order to improve the quality of clinical trials of anti-tumor drugs.
作者
刘龙
漆璐
王进
王瑜
王兴河
LIU Long;QI Lu;WANG Jin;WANG Yu;WANG Xing-he(Phase I Clinical Trial Center Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2019年第4期396-398,共3页
The Chinese Journal of Clinical Pharmacology
基金
国家科技重大专项-重大新药创制基金资助项目(2017ZX09304026)
关键词
抗肿瘤药物
临床试验
不良事件
规范化判断
anti-tumor drug
clinical trial
adverse event
standardized judgment
