The resources below were developed by the Value of Safety Information Data Sources (VSIDS) Initiative in an effort to identify sources of safety information for single high value valid cases and support development of a proposed method for aggregate reporting of lower value cases.
Value of Safety Information Data Sources Materials
The volume of adverse events (AEs) collected, analyzed, and reported has been increasing at a rapid rate for over the past 10 years, largely due to the growth of solicited programs. The proportion of various forms of solicited case data has evolved over time, with the main relative volume increase coming from Patient Support Programs. In this study, we sought to examine the impact of the pooling of AE report data from solicited sources with data from spontaneous sources to safety signal detection using disproportionality analysis methods.
The study examined the increase in adverse event reports due to patient support programs, market research programs, and social media has impacted pharmacovigilance. This study did not demonstrate that these data sources meaningfully contributed to the further understanding of the characterization of a product’s safety profile.