Centralized Endpoint Adjudication

In contrast, in cases where a drug is compellingly identified as unacceptably toxic, ethical considerations support termination in a clear manner. 

6 Meta-analysis, Group Sequential Study Designs, and other topics 

Independent, blinded, clinical endpoint committees are regularly conunissioned to adjudicate potential cardiovascular endpoints in trials examining the efficacy of cardiovascular drugs as well as cardiovascular endpoints in cardiovascular safety outcome studies (see Seltzer et al. 2015). 

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Vaduganathan M, Prasad V (2016) Cardiovascular risk assessment in oncological clinical trials is there a role for centralized events adjudication Eur J Heart Fail 18 128-132 Westerhout CM, Bakal JA (2015) Novel approaches to composite endpoints in clinical trials. Eurointervention 11 122-124... 

The size and hence geographical distribution of investigational sites needed for the large cardiovascular safety outcome trials discussed in Chap. 13 mean that there can be a considerable degree of variability in the identification of cardiovascular endpoints of interest since classification of events as actual study endpoints is a partially subjective process based on the application of a complex set of medical endpoint criteria to an often complex clinical event. Regulatory agencies therefore require the centralized adjudication of these events to control for the impact of this variability in identification and thereby to generate data for use in statistical analyses that are as standardized as possible. 

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