Beauty Can Be in the Eye of the Beholder, but Consistency Should Not

• Activity Number: 519
• Type: Topic Contributed
• Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Bruce Binkowitz*+
• Companies: Merck & Co Inc
• Keywords: consistency ; multi-regional ; clinical trial

Abstract

Developing new drugs, vaccines, devices and biologics requires addressing not only demanding scientific and medical questions, but doing so in a heterogeneous regulated environment. Health authorities are charged with ensuring and enhancing public health, and the nature of these obligations are often more local than global. Conducting the necessary trials in this environment to demonstrate efficacy and safety is challenging. Collecting the necessary evidence often requires trials on a global scale. In contrast, local health authorities will look at the global results as well as the results relevant to their local area of public health. Like the concept of Beauty, Consistency can be in the eye of the beholder. But Consistency should not be subjective. This presentation will discuss barriers to consistency, methods to address those barriers, and what statisticians should proactively do to address the concept of consistency, from design to analyses of a multi-regional clinical trial.