All Times EDT
Keywords: Safety, Blinded safety monitoring, Evidence synthesis
During 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. However, maintaining the trial blind is necessary to avoid jeopardizing the validity of study findings. 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. This roundtable will discuss current developments in the application of blinded analysis in ongoing aggregate safety monitoring and evaluation. First, we will cover the needs of synthesis blinded and unblinded studies together in order to characterize the evolving safety profile of medicinal products at the program level. Next, we will discuss how the blinded safety monitoring process can accomplish the planned unblinded analyses to further quantify risks of medicinal products and refer safety concerns for medical review and safety reporting.