Drug safety monitoring teams are under constant pressure to stay current with emerging data, but traditional evidence reviews can’t always keep up. By the time a systematic literature search is finalized, new studies may already have shifted the risk profile of a product or revealed safety signals that never made it into the last report.
Living evidence reviews can help close that gap. They maintain the rigor of a systematic process but allow integration of new information as it appears. For pharmacovigilance teams, this means their safety summaries, signal assessments, and regulatory updates are always based on the most current evidence available.
What Makes an Evidence Review “Living”?
A living evidence review (LER) is a systematic review that never goes dormant. Instead of producing a single static summary, it evolves as new data become available, using the same protocol, search strategy, and inclusion criteria for each addition. Searches are rerun on a defined schedule or when a trigger occurs (e.g., a new publication, safety signal, or regulatory requirement). Each update is documented with version control, so reviewers can see exactly what changed and when. This preserves the scientific discipline of a traditional systematic review while adding flexibility.
| Type of Review | Purpose | Update Frequency | Rigor & Transparency |
|---|---|---|---|
| Narrative Review | Summarizes published information; often descriptive or opinion-based | Ad hoc, as needed | Low – methods may not be reproducible |
| Systematic Literature Review (SLR) | Comprehensive synthesis following a defined protocol | Static; updated manually when repeated | High – but can become outdated quickly |
| Living Evidence Review (LER) | Systematic, protocol-based synthesis with ongoing updates | Continuous or triggered by new data | High – includes governance and traceable version control |
The Benefits of Living Evidence Reviews
For pharmacovigilance and clinical literature monitoring teams, safety data rarely stand still. New case reports, real-world findings, and postmarketing studies can quickly reshape the understanding of a product’s risk–benefit profile. Traditional systematic reviews capture a moment in time but living evidence reviews give sponsors a way to stay current without rebuilding their evidence base from scratch.
Choosing when to move from a traditional review to a living model depends on the nature and pace of the evidence being tracked. The goal isn’t to make every review “living,” but to apply the approach where ongoing updates create meaningful value, particularly for products or therapeutic areas with evolving safety data.
Factors to consider when deciding whether a living evidence review is the right fit include:
- Evidence volatility: Are new studies, case reports, or safety findings emerging frequently?
- Regulatory commitments: Does the product require regular evidence submissions or continuous monitoring?
- Therapeutic area: Are data evolving rapidly, such as in oncology, vaccines, or new therapeutic areas?
- Life cycle stage: Is the product in active postmarketing surveillance or under label expansion?
- Operational readiness: Do governance structures exist to manage version control and document updates efficiently?
Building a Sustainable Evidence Review Framework
The strength of a living evidence review lies in its structure. To stay reliable over time, the process must balance automation with human oversight, ensure transparency, and align outputs with the needs of drug safety monitoring and related teams.
Core elements of an effective living evidence review include:
- A predefined protocol: Mirrors the rigor of a systematic review (e.g., PICO framework) and can be registered to maintain transparency
- Ongoing search and screening cycles: Updates are triggered by new evidence or predefined intervals, ensuring relevance without unnecessary rework
- Governance and version control: Each iteration is documented, allowing teams to trace how the evidence base has evolved
- Cross-functional coordination: Ensures outputs inform pharmacovigilance activities such as signal detection, PSURs, and regulatory updates, while remaining available for other groups (e.g., clinical or HEOR) as needed
- Pragmatic use of automation: Tools can streamline repetitive tasks like deduplication or alerts, but expert review remains central to interpretation and quality control
Getting Started With a Living Evidence Review
For sponsors considering a living model, the key is to start structured and stay consistent. A clear framework helps ensure that updates remain manageable, defensible, and aligned with broader pharmacovigilance priorities.
A quick-start checklist for sponsors:
- Define the purpose and scope of the review, including which evidence questions need to remain current
- Establish triggers for updates, whether time-based, event-driven, or tied to regulatory milestones
- Maintain a clear protocol outlining processes: inclusion criteria, data sources, and review methods
- Set up version control and documentation practices to track every change
- Define how outputs will feed into PV reporting, signal detection, and inspection-readiness activities
- Assign governance ownership to ensure each update follows a consistent process
Choosing the right partner is also an essential consideration, and Ephicacy is ready to support your drug safety monitoring needs. We bring depth in biometrics, evidence review methodology, and pharmacovigilance data integration. Our teams help sponsors establish clear governance, maintain traceable updates, and ensure that evolving evidence translates seamlessly into safety and regulatory deliverables.
Contact us to discuss how we can help your team keep evidence current and decision-making confident.
