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.
A metadata standard is a high level document that establishes a common way of structuring and understanding data, and includes principles and implementation issues for utilizing the standard. It helps to record their collections and processes and to structure this information, and can be used to validate data integrity and quality. Metadata standards improve the quality and interoperability of information across information technology platforms by increasing compatibility, improving the consistency and efficiency of information collection, and reducing redundancy. This article introduced the progress and features of metadata standards of clinical research, and aimed to promote the standardization of clinical research and scientific process of therapeutic evaluation.