ABSTRACT

The trial design element of the study development process depicted in Figure 2.1 can be parsed into two distinct components: (1) determining what data is to be collected and (2) ensuring the intended data is collected. The intent of this chapter is not to provide a broad discussion of both components. This chapter addresses the second component of ensuring that the intended data is collected. The focus is on practical aspects of preventing missing data, which is important regardless of the specific design-regardless of what data was intended to be collected. For general texts on clinical trial design, see Piantadosi (2005).