FDA/CBER Biologic Product Evaluation Using Observational Studies

• Activity Number: 53
• Type: Invited
• Date/Time: Sunday, August 4, 2013 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Yun Lu*+
• Companies: Food and Drug Administration
• Keywords: Observational ; Post-licensure ; Biologics ; Safety Surveillance ; Confounders ; Bias

Abstract

The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration regulates biological products such as vaccines, blood, tissues, and allergenics. Pre-licensure clinical trials are often under powered for detecting rare drug/vaccine related adverse events, and post-licensure observational studies are increasingly utilized by CBER to perform post-marketing safety surveillance as well as to conduct post-approval effectiveness assessment. This talk will cover statistical and epidemiological challenges related to observational studies at CBER such as accounting for delay in claims when performing near real-time safety surveillance; controlling for time constant and time-varying confounders; quantifying bias associated with the study.