Sequential Analytic Methods for Prospective Drug Safety Surveillance

• Activity Number: 50
• Type: Invited
• Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
• Sponsor: ENAR
• Author(s): Lingling Li*+
• Companies: Harvard Medical School/Harvard Pilgrim Health Care Institute
• Keywords: sequential analytic methods ; drug safety surveillance ; adverse events detection ; observational healthcare databases ; sequential probability ratio test ; pharmacovigilance

Abstract

The importance of active post-marketing surveillance for drug and vaccine safety is well recognized as rare but serious adverse events may not be detected in pre-approval clinical trials. In such surveillance, a sequential test is preferable, in order to detect potential problems as soon as possible and control the overall rate of false signals. We will introduce and discuss some sequential analytic methods that have been developed for such safety surveillance studies using existing electronic healthcare databases. We will also discuss remaining issues that need to be addressed by novel statistical methods.