The Application of Global Benefit-Risk Score in Clinical Trial Design and Some Statistical Considerations of the Method

• Activity Number: 315
• Type: Topic Contributed
• Date/Time: Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Yili Pritchett*+ and Roy Tamura
• Companies: Eli Lilly and Company and Eli Lilly and Company
• Keywords: Benefit-risk analysis ; Global benefit-risk score ; Clinical trial design ; GBR

Abstract

When characterizing a therapy, two major aspects will be under consideration: the efficacy and the safety. In prescribing a therapy to a patient, a clinician puts the two aspects together and makes a decision based on a consolidated thought process. In the clinical trials that make head-to-head comparisons between two active treatments, a comparison based on these two major aspects of the therapy should deliver the information needed in clinical practice. In this presentation, we will talk about how the global benefit-risk (GBR) linear score (Chuang-Stein 1991) was used as the primary outcome measure in designing clinical trials comparing two antidepressants. We will describe the definition of the benefit and risk categories and the selection of a prior weight function. We will discuss the relationships between linear and ratio GBR scores and the sensitivity of this approach in the face of the selective nature of the weight score. Finally, we will illustrate statistical considerations using the data from the clinical trials where GBR linear score was specified as the primary outcome measure.