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

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 resear...

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

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.