DIA 2020 Global Annual Meeting

Data Monitoring Committee (DMC) plays a vital role in determining the direction of an ongoing clinical trial. The DMC gets ongoing views of trial data and findings before submission to any regulatory agency. The results of the interim analysis can affect crucial trial design changes, such as sampling methodology, recalculation of sample size, or early stopping decisions due to futility, safety signals, or overwhelming efficacy. Therefore, the DMC might recommend altering the trial from its original design based on issues arising during the trial. Since the DMC has a unique opportunity for first view of the unblinded data, it can assist in monitoring the progress of the trial and oversee data quality issues to ensure the trial integrity. On the other hand, central data monitoring and proper statistical process control during the trial can mitigate issues caused by data anomalies and the impact of trial misconduct, before the submission is sent for regulatory review. Familiarity with available data monitoring tools will help in accomplishing these tasks. This session will provide a platform for trial designers and analysts from industry and regulatory agencies to discuss the proper role of the DMC, in particular, how it can be utilized to address issues of data quality and detect potential misconduct.