CDISC COVID-19治疗领域标准用户指南及其相关标准解读

Introduction of CDISC therapeutic user guide for COVID-19 and its related standards

新型冠状病毒肺炎(COVID-19)已被世界卫生组织(WHO)评估为大流行病。尽管已研发了多个保护效果超过50%的疫苗,但在治疗方面,瑞德西韦仍是经过美国食品药品监督管理局(FDA)有条件批准用于治疗COVID-19的抗病毒药物,而其他治疗方案均未有足够的临床证据推荐使用。国内外已注册了多个临床试验以开发安全有效的治疗药物或疫苗。为更好地促进COVID-19临床研究数据的采集、制表与分析,提高临床研究效率,同时促进多个同类研究数据整合、共享和二次分析,临床数据交换标准协会(CDISC)开发了COVID-19治疗领域标准用户指南及基于WHO和国际严重急性呼吸道与新兴感染联合会联合开发的用来收集COVID-19相关临床特征的注释病例报告表(aCRF)和数据相关映射表格。此外,CDISC开发制订了《因COVID-19暴发而中断运行的研究的指南》及临时分析数据模型(ADaM)指南,以帮助受影响的临床试验采集存储和分析相关数据。本文介绍该指南及其相关标准的结构与内容,以期促进其在国内的COVID-19临床试验及因COVID-19大流行而中断运行的研究中的应用。

The coronavirus disease 2019(COVID-19)has been evaluated as a pandemic by the World Health Organization(WHO).Although several vaccines with an efficacy of more than 50%have been developed,in terms of treatment,remdesivir remains the antiviral drug approved by the U.S.Food and Drug Administration(FDA)for the treatment of COVID-19,while none of the other treatments has been recommended by FDA due to insufficient clinical data.A number of clinical trials have been registered to study therapeutic drugs or vaccines for COVID-19.To promote the collection,tabulation,analysis of COVID-19 clinical research data,improve the efficiency of clinical research,and facilitate the integration,sharing and secondary analysis of multiple similar research data,CDISC has developed a therapeutic area user guide for COVID-19 and resources for public health researchers.The resources included two documents,one is a SDTM annotated CRF based on ISARIC and WHO core COVID-19 case report form,and the other is SDTM and CDASH mapping spreadsheet.Moreover,CDISC has developed the guidance for ongoing studies disrupted by COVID-19 pandemic and interim ADaM guidance for ongoing studies disrupted by COVID-19 pandemic to help disrupted clinical trials to collect,store,and analyze relevant data.This paper introduced the structure and content of the guide and its related standards,with a view to promoting its application in COVID-19 clinical trials and in ongoing studies disrupted by COVID-19 pandemic.