, Volume 33, Issue 10, pp 1815-1818
Date: 28 Jul 2007

A primer on data safety monitoring boards: mission, methods, and controversies

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access
This is an excerpt from the content

Introduction

Since 1967 when they were first proposed [1], the prevalence and impact of data safety monitoring boards (DSMBs) has increased substantially. A basic understanding of DSMBs (also frequently called data monitoring committees) is important for intensivists because intensive care trials inevitably assess major morbidity or mortality end-points and often involve vulnerable patients. As well, a number of important trials in intensive care medicine have been impacted by DSMB recommendations and/or by safety concerns [2, 3]. This contribution reviews emerging guidelines for DSMBs and highlights areas of controversy.

DSMB mission

The European Medicines Agency (EMEA), the British National Health Service Health Technology Assessment Program, and the United States Food and Drug Administration (FDA) have all recently published recommendations regarding the roles, responsibilities, and functions of DSMBs [46]. While these documents differ on some points, there is general agreement that t ...