TeGenero

NPR Interviews David DeMets on Drug Safety Monitoring Boards

Tuesday, June 13, 2006

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…

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