Common Practices in Industry for Subgroups Identification and Analysis in Clinical Trials

• Activity Number: 285
• Type: Invited
• Date/Time: Tuesday, August 11, 2015 : 8:30 AM to 10:20 AM
• Sponsor: ENAR
• Author(s): Cristiana Mayer*
• Companies: Janssen R&D/Johnson & Johnson
• Keywords: subgroup analysis ; subgroup identification ; clinical trials ; survey ; QSPI

Abstract

The Subgroup Analysis Working Group sponsored by the industry group QSPI (Quantitative Sciences in the Pharmaceutical Industry) was formed in 2013 with the primary goal of creating a unifying and transparent framework for the current state of subgroup analysis/identification statistical methods and their application in drug development. Because there are many purposes of subgroup analyses, from evaluating consistency of results across subpopulations, to determining a subgroup of patients with an enhanced treatment effect for personalized medicine, the analysis of subgroups is very common in clinical trials. However the implications of different types of subgroup analyses (e.g. exploratory versus confirmatory) are often not well understood. With the current EMA draft "Guideline on the investigation of subgroups in confirmatory clinical trials" (February 2014) the interest in subgroup identification and analysis has gained momentum. In order to describe the current practices, the Working Group developed and conducted a survey early this year which was disseminated to statisticians in the pharmaceutical industry. This effort also aimed to identify important issues and the most common