Clinical Drug Development Decision Points

CRITICAL CLINICAL DRUG DEVELOPMENT DECISION POINTS 

Once one recognizes that the end product of clinical drug development is the knowledge and 

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CRITICAL CLINICAL DRUG DEVELOPMENT DECISION POINTS... 

For those who desigii/ track/ and make decisions regarding the progress of clinical development programs/ the inclusion within the development plan of critical decision pointS/ with prespecified go/no-go criteria/ provides a focus for the clinical development team. The key clinical drug development decisions are identified in Table 33.2/ with the critical go/no-go decisions being shown in boldface. These critical decisions will be expanded on later in this chapter. It is important to note that the driver for these decisions is our question-based label-driven clinical development plan. Indeed/ the creation of a label-driven question-based clinical development plan not only increases the efficiency and speed of the clinical development process/ but also supports the question-based review by the FDA of an NDA/ as described by Lesko and Williams (35). 

The life cycle of a new drug is illustrated in Figure 1. As shown, the process consists of sequential phases and milestones. The phases are defined by the stages of preclinical and clinical development leading to market launch. In practice, the development phases are rarely discrete so that only the decision points clearly mark progress. 

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