Data and Safety Monitoring Committees in Clinical Trials

摘要

Arc you capable of preserving 'the credibility of the trial and the aegis of patient safety"? Dr Herson specifies that the responsibility of the data and safety monitoring committee (DSMC) is to have 'stewardship' of the trial and to do such preservation. It is an important role that many statisticians face, requiring various skills, considering issues of trial design, power, blinding and interim analyses and communicating these issues appropriately and effectively. My perspective is based on becoming a DSMC statistician member for the first lime. Hence, 1 was most interested in the section about the formal of the meeting(s), the data thatrnare to be reviewed and my responsibilities within the DSMC. When searching for books about DSMCs you will find that Ellenburg et al. (2002) published a book with an almost identical title to Herson's.