Statistical Methods for Benefit-Risk Assessment to Meet Regulatory Agency Requirements

• Activity Number: 208
• Type: Roundtables
• Date/Time: Monday, August 10, 2015 : 12:30 PM to 1:50 PM
• Sponsor: Health Policy Statistics Section
• Author(s): T. Ceesay*
• Companies: Merck
• Keywords: benefit risk ; therapeutic area ; regulatory

Abstract

It is important that both efficacy and safety are taken into consideration when assessing the merit of drugs so that patients are only exposed to drugs for which the benefit outweighs the risk. It is especially important in the current environment, in which "value" (in addition to efficacy and safety) is an integral part of global health policy to assess the practicality of a new drug or therapy. Various comparative benefit-risk methods can be used to assess the superiority of one therapy or drug over another depending on the therapeutic area. The discussion will focus on the statistical methods that have been and can be used for comparative benefit-risk assessment in various therapeutic areas. Challenges of developing and implementing a method for comparative benefit-risk assessment to satisfy regulatory requirements also will be discussed.