Safety signal assessment is the process of evaluating a validated signal by considering all available relevant evidence from different sources to confirm or refute the event as an adverse drug reaction.
Signal assessment typically relies on analysis of pharmacovigilance databases, clinical trial data, and scientific literature. In addition to these sources, there may be a need to further evaluate the signal by conducting formal protocolized Real World Data (RWD) studies. These RWD studies can provide additional robust evidence. However, such studies are often resource and time-intensive, meaning that they are seldom feasible given signal assessment timelines.
To help address the resource and time constraints of traditional safety assessment, this initiative aims to evaluate current practice and identify novel opportunities to complement signal assessment with rapid RWD analyses. Furthermore, this initiative is offering a Framework for RSA and an Alternative to a Full Protocol. Increasing use of RWD in safety signal assessments may bring awareness to potential safety issues sooner and thus promote patient safety and public health.
Current State Publication
The “Summary of Current Practice Findings” will be released in 2024.
Framework for Rapid Signal Assessment Using RWD
The RSA RWD Framework provides an end-to-end high level process map on using RWD as an option to more rapidly conduct safety signal assessments. It includes a series of elements/components designed to additionally help stakeholders have a common understanding and communication of concepts and processes for RSA RWD. Components of the framework include a:
- glossary (definitions)
- rapidity challenges and opportunities
- a proposed process
- example use cases
This document includes considerations on how to apply the framework’s principles in ways that support quality, scientific rigor, and robustness of RWD evidence.
Alternative to a Full Protocol for RSA
The Alternative to a Full Protocol offers a potential alternative to a full study protocol for use in the rapid safety signal assessment (RSA) process, which is described in the RSA RWD Framework. It is a generic template for rapid non- or less-complex RWD analyses types, which typically would not require a full study and protocol, along with guidance for its usage. In scope for use of this template are Rapid RWD analyses for signal assessment, out of scope are full observational studies (e.g. PASS).
Read the Journal Article in Clinical Leader by Vaishali Patadia, head of signal management & safety risk management CoE in global patient safety, Amgen: Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities