Rationale
“Safety signal assessment” is a central step of the signal management process and is crucial for the safe and appropriate use of medicines. As part of the overall signal management process, safety signal assessment is the process of evaluating a validated signal by considering all available relevant evidence from different sources to confirm or refute a signal.
This process is regulated, time-bound, and typically relies on analyzing internal and external pharmacovigilance databases, clinical trial data, and scientific literature. These sources may be insufficient to conclude signal assessment. Formal protocolized RWD studies can provide additional robust evidence. However, such studies are often resource and time-intensive, meaning they are seldom feasible given signal assessment timelines.
This initiative will conduct a landscape assessment of methods and processes currently in use for rapid use of RWD in safety signal assessment. This landscape assessment will enable the initiative to identify potential opportunities as input for further work to examine additional solutions.
Benefits
- Highlight industry best practices and identify the value to enhance the current processes.
- Provide stakeholders with awareness of gaps and potential opportunities.
- Provide the basis to engage with health authorities to share findings.