Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, ...

Integration of trial sequential analysis to control random errors in meta-analysis findings ... Figure 1 shows the PRISMA flow diagram of the literature selection in this study. Actual screening ...

Introduction One of the leading causes of global child mortality continues to be diarrhoea where rotavirus contributed to about 24% of deaths among all diarrhoeal deaths, mostly in low-income and ...