Regulatory issues meta-analysis

Regulatory Issues in Meta-Analysis of Safety Data ... [Pg.237]

In this chapter, we discuss the use of meta-analysis of randomized trials conducted in the regulatory context for the evaluation of safety. The chapter discusses key design, methodological, and reporting issues. We also present two real-life examples that had regulatory consequences and display many of these issues. [Pg.238]

Perhaps the most important concept of meta-analysis in the regulatory context is prespecification. This concept for meta-analysis is more multifaceted than for the case of a single trial. For example, a meta-analysis can be conducted based on completed trials. In this case, it is likely that the results from the completed trials influence the objectives and design of the meta-analysis. If a trial has identified a safety issue for a drug, including such a trial in a meta-analysis to confirm the safety signal is problematic, since in this case the meta-analysis will not provide independent findings. [Pg.239]

Addresses regulatory issues in the meta-analysis of safety data... [Pg.355]

Big Chemical Encyclopedia