Monitoring trial effects

Abstract

In order to address difficulties in running RCTs, clinicians introduced the concept of a totally objective group of assessors to continually evaluate and review trial results and execution. These groups are known as Data Monitoring Committees (DMC) and have been set up to minimise trial complications while also optimizing trial implementation. Furthermore, as it quickly became apparent that the results of some trials had significant implications for patient care before trials had been completed, the DMCs who are responsible for the continual review of trial data also adopted the power to stop or advise extension of each experiment if deemed scientifically necessary. This chapter delineates the role of these committees, and also clari-fies some of their functions through some surgical trial examples. © Springer-Verlag Berlin Heidelberg 2010.