Concluding comments on safety assessments in clinical trials

Categorical analyses are based on the number and the percentage of individuals who meet or exceed a predefined upper limit. Such limits can be stated in the study protocol in terms of either 

For further discussion of QT/QT,. interval prolongation and other cardiac safety assessments for noncardiac drugs, see Morganroth and Gussak (2005) and Turner and Durham (2008). 

5 Concluding comments on safety assessments in clinical trials 

The analysis tools that we have described in this chapter provide ways to evaluate the risk of the new drug, given the constraints of sample sizes obtainable in clinical development. The limitations of relatively little human experience 

Chapter 9 Confirmatory clinical trials Safety data II 

---