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.

Citation： LI Geng, WEN Zehuai. Introduction of CDISC therapeutic user guide for COVID-19 and its related standards. Chinese Journal of Evidence-Based Medicine, 2021, 21(11): 1358-1364. doi: 10.7507/1672-2531.202105129 Copy