新型冠状病毒肺炎疫情期间临床试验工作现状的调查与研究  

Investigation and research on the state of clinical trials during epidemic period of COVID-19

作　　者：朱晓芳[1] 戴建[1] 刘灵烨 朱静静[1] 鲁萌[1] 王璐璐[1] 朱青[1] 王健[1] ZHU Xiao-fang;DAI Jian;LIU Ling-ye;ZHU Jing-jing;LU Meng;WANG Lu-lu;ZHU Qing;WANG Jian(National Drug Clinical Trial Institution of the Affiliated Drum Tower Hospital of Nanjing University Medical School,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院国家药物临床试验机构,南京210008

出　　处：《中国新药杂志》2021年第1期50-54,共5页Chinese Journal of New Drugs

基　　金：多学科联动的心衰患者信息化延续护理方案的构建与应用课题资助项目(NDYG2019014)。

摘　　要：新型冠状病毒肺炎疫情蔓延下,临床试验工作的节奏遭受巨大挑战,南京大学医学院附属鼓楼医院基于疫情期间临床试验工作指引和相关法规,通过设计调查问卷,调研临床试验工作开展现状并进行分析,对在研项目的研究者、临床监查员(clinical research associate,CRA)、研究协调员(clinical research coordinator,CRC)、试验管理人员进行调研。调查显示,大多数研究人员认为临床试验进度受影响(68.24%),非口服药临床试验影响较大(69.96%),主要表现在恶性肿瘤项目(88.2%),试验过程中访视超窗影响最为明显(92.7%),并且受试者担忧疾病恶化(78.97%),邮寄药物存在药物超温的风险(60.09%),试验数据及时性(89.09%)和完整性(79.61%)最受影响。因此,完善临床试验应急机制,加强试验监管,实现临床试验数据共享和全程信息化管理,是临床试验机构将探索的一种新的工作模式。With coronavirus disease 2019(COVID-19)spreading,the rhythm of clinical trials has been challenged.Based on the guidelines and relevant regulations of clinical trials during the epidemic period,the Drum Tower Hospital Affiliated to Nanjing University School of medicine has designed a survey to investigate the current situation of clinical trials.Association,CRA,clinical research coordinator(CRC),and test managers were involved in the research.According to the survey results,most researchers reflected that the progress of clinical trials was affected(68.24%),and the clinical trials of non-oral drugs were greatly affected(69.96%),which was mainly manifested in the malignant tumor project(88.2%),during the trial,the most obvious influence is 92.7%for out of visit window,and the subject worrying about the deterioration of disease(78.97%),the risk of drug overtemperature exists in mailing drugs(60.09%),and the number of trials timeliness(89.09%)and integrity(79.61%)were the most affected.Therefore,it is a new working mode for our clinical trial institutions to improve the emergency mechanism of clinical trials,strengthen the supervision of trials,and realize the sharing of clinical trial data and the whole process information management.

关 键 词：新型冠状病毒肺炎 临床试验 数据共享 工作现状调查 临床试验调查与研究 

分 类 号：R969.4[医药卫生—药理学]