Antimicrobial Products: Statistical Challenges and Opportunities

Abstract

According to a 2013 report of the Centers for Disease Control and Prevention, more than 2 million people in the United States develop illness from antibiotic-resistant infections yearly and at least 23,000 die as a direct result of antibiotic-resistant infections. Despite an alarming number of antibiotic-resistant infections, antibacterial drug development has been slow. The consequences of the lack of new effective antibiotics may be dire to our global public health.There are scientific, economic, and regulatory challenges that underpin the sparse antibiotic pipeline. In this article, we outline critical design and analysis elements that impact clinical trials of new antibiotics and include some of the complex scientific challenges unique to antibacterial products. The challenges also present opportunities for statisticians to provide innovative strategies to the design and analysis of these trials.