新冠肺炎疫情下信息化助力抗肿瘤药物临床试验质量保证

Informatization Helps the Quality Assurance of Anti-cancer Drug Clinical Trial During the Epidemic of COVID-19

新型冠状病毒肺炎(COVID-19)疫情发生以来,各地陆续启动重大突发公共卫生事件一级响应,严重影响了药物临床试验尤其是抗肿瘤药物临床试验的开展。一方面,部分抗肿瘤药物临床试验受试者完成访视的难度增加,导致试验数据缺失;另一方面,也给临床试验质控体系带来了极大挑战。本文以我院药物临床试验机构为例,介绍疫情防控期间信息化手段全方位助力抗肿瘤药物临床试验的持续推进,全流程保证临床试验质量的作用,以期为各机构在疫情等特殊情况下采取信息化应对措施确保试验质量提供一定的借鉴和参考。

Since the epidemic of Coronavirus Disease 2019(COVID-19),many public health emergencies have been successively launched in different places,which has seriously affected the clinical trials of drugs,especially the clinical trials of anti-cancer drugs.On the one hand,it becomes more difficult for some subjects in clinical trials of anti-tumor drugs to complete the visiting,resulting in the lack of experimental data.On the other hand,it brings great challenges to the quality control system of clinical trials.In our study,we ensured the quality of clinical trials of anti-cancer drugs by means of informatization during the epidemic of COVID-19.This study provides some references for institutions to take information response to ensure quality of clinical trials under special circumstances like COVID-19 epidemic.