All Times EDT
Keywords: centralized statistical monitoring, quality tolerance limits, risk based quality management, risk based monitoring, post pandemic trial conduct
The COVID-19 pandemic caused several challenges for clinical trials. On-site source data verification (SDV) in multicenter clinical trials became difficult due to travel ban and social distancing. These challenges resulted in a fundamental shift from the traditional on-site monitoring paradigm to one that is more inclusive of centralized statistical monitoring which will likely continue in a post-pandemic setting.
The most commonly used on-site monitoring techniques are not optimal in finding data fabrication, tampering, non-random data distributions, scientific incompatibility between key measures of interest etc. with the greatest potential for jeopardizing the validity of study results. Quality tolerance limits (ICH E6 R2) are used to proactively control systematic risks to factors critical to quality. QTLs combined with statistical monitoring techniques reduce spending on inefficient on-site monitoring practices, resulting in diverting resources to increase sample size or conduct more trials.
Centralized statistical monitoring and quality tolerance limits (CSM/QTL) scientific working group was recently endorsed by EFSPI Council, PSI Board and ASA BIOP. This roundtable organized by the working group will provide the relevant framework to gather perspectives from participants on risk assessment and identification of relevant data and information deemed critical for quality tolerance limits and centralized statistical monitoring. Examples of studies using CSM, and QTLs will help facilitate dialogue and gather insights from participants in industry and FDA on how to best harness the power of statistical monitoring tools, address common questions that come up with QTLs and facilitate broader adoption of such tools in post pandemic trial conduct to better manage risks and achieve targeted actions.