The relationship between research questions and study design

17 The relationship between research questions and study design 

Having introduced and discussed research questions in this chapter, the following quotes from authoritative sources emphasize their importance  

The most critical and difficult prerequisite for a good study is to select an important feasible question to answer. Accomplishing this is primarily a consequence of biological knowledge. (Piantadosi, 2005) 

The essence of rational drug development is to ask important questions and answer them with appropriate studies. (ICH Guidance E8, 1997) 

Between them, these quotes capture the notion that, once an important research question has been formulated, a good and appropriate study must be conducted to answer the question. As you have seen already, we provide operational definitions of terms that are used in statistical contexts. Accordingly, Chapter 4 provides operational definitions of the terms good and appropriate in the context of deciding how best to answer an important research question. 

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Chapter 3 introduced the central topic of research questions in clinical trials. It also introduced the null and alternate hypotheses. This chapter discusses the relationship between research questions and study design, and shows how optimum experimental methodology is critical to the successful implementation of studies conducted to answer research questions. 

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