Meta-analysis of blinded and unblinded studies for ongoing aggregate safety monitoring and evaluation

During the course of clinical development, ongoing aggregate safety monitoring and evaluation are needed to understand the evolving safety profile and to ensure effective risk-management strategies for medicinal products. CIOMS reports and global regulatory guidance (including from ICH, US FDA, and EMA) compel sponsors for assessment of safety based on aggregate data. To identify and characterize the risks of medicinal products at a program level in a more timely and informed manner, aggregate safety evaluations should combine all available information, including from ongoing blinded trials, completed unblinded trials, and other data sources.
Source: Contemporary Clinical Trials - Category: Radiology Authors: Source Type: research