In the wake of Vioxx and the recent events during the German biotech TeGenero AG’s trial, involving a severe immune reaction in six British subjects given an investigative monoclonal antibody, the industry has made a major effort to review trial safety precautions. Among other areas under scrutiny, the work of independent review boards (IRBs) has received much attention. Recently, the roles and challenges of Data Safety Monitoring Boards (DSMBs) have also been discussed in preventing further safety issues during clinical trials AND after market approval...

Hoping to shed some light on the subject, National Public Radio (NPR) recently conducted an interview with David DeMets, the chairman of the Department of Biostatistics and Medical Informatics at the University of Wisconsin. DeMets has also authored of several books on trial monitoring, and co-edited the book “Data Monitoring in Clinical Trials: A Case Studies Approach” with Dr. Curt Furberg Professor at the Department of Public Health Sciences at Wake Forest University and Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications at the National Heart, Lung, and Blood Institute.

The complete interview can be read on the NPR website.