All Times EDT
Keywords: missing data, COVID, Quality Tolerance Limits
COVID-19 had (and still has) the potential to have a major impact on ongoing clinical trials including the potential for missing data as well as loss to follow-up. Guidance has been provided from regulators and industry experts on minimizing risks to trial integrity for the duration of the COVID-19 pandemic. A critical component to minimizing risks to trial integrity is tracking missing data. In recent years quality tolerance limits (QTL) and key risk indicators have been leveraged to identify systemic issues that can impact the reliability of trial results. We sought to leverage QTLs and the risk based monitoring framework to develop focused metrics to track leading indicators of potential issues with primary efficacy endpoints with the understanding that missing data for some assessments have greater impact on trial integrity than others and that the impact of missing data differs based on the type of endpoint and the status of the trial. Example metrics for endpoints that rely on single timepoint assessments as well as metrics for more complex endpoints such as progression-free survival will be illustrated.