Nonclinical Safety Assessment: An Introduction for Statisticians

Abstract

This chapter provides an overview of the nonclinical drug safety testing process, and the statistical challenges associated with work in this area. Whilst other chapters in this book focus on specific types of designs and analyses which you may encounter during nonclinical drug development, we provide here the context for a statistician working in nonclinical safety assessment, and seek to prepare them for some of the practical issues and decisions they are likely to face. We will describe the scope and framework for the studies run within a nonclinical safety assessment programme, and recommend when and how a statistician needs to engage to add value. We will look generally at design and analysis considerations for safety studies which, whilst not unique to this context, are particularly pertinent to this area of work. Finally we will highlight some practical considerations and industry trends. If this chapter provides you with insight that complements rather than replicates what is taught in conventional statistics courses, and inspires you to believe that statistical work in this area can be both valuable and rewarding, we will have achieved our goal.