Rationale
The number of adverse events collected by biopharmaceutical companies and reported to regulatory authorities is increasing 10 – 20 % per year. There is evidence that this increase is not only caused by individual patients or health care providers reporting their adverse experience to companies or regulatory authorities, but is mainly driven by the identification of adverse events through patient support programs, social media etc. There is no evidence that this type of volume growth has resulted in a more rapid signal detection or better protection of public health; given the increasing amount of effort required to collect, analyze and report on this type of information, it needs to be recognized that our ability to detect a new safety risk may be hindered. In addition, differences exist across biopharma companies in defining how these various sources of information should be collected, processed and submitted to the regulators, either as aggregate or individual safety reports.
The Value of Safety Information Data Sources Initiative identified sources of safety information for single high value valid cases and developed a proposed method for aggregate reporting of lower value cases. This hierarchy of values was based on the evidence derived from the collective experience of drug companies and other stakeholders.
Benefits
The Value of Safety Information Data Sources Initiative benefits patients, sponsors, and regulators through:
- Improved patient safety by enhancing safety signal detection
- Increased efficiencies for sponsors and regulators by sharpening the focus on the highest value safety information
Available Solutions
For more information and to explore our solutions, visit our Initiative Solution page.