The Value of Source Data Verification in a Cancer Clinical Trial

In this empirical comparison, SDV was expensive and identified random errors that made little impact on results and clinical conclusions of the trial.

Abstract

Quality assurance methods used in clinical trials should be informed by empirical evidence. In this empirical comparison, SDV was expensive and identified random errors that made little impact on results and clinical conclusions of the trial. Central monitoring using an external data source was a more efficient approach for the primary outcome of OS. For the subjective outcome objective response, an independent blinded review committee and tracking system to monitor missing scan data could be more efficient than SDV.