Rationale
The current practice of managing and sharing ICSRs across the ecosystem, established in the 1960s, has become inefficient, burdened with ICSR duplication and replication, and results in a fragmented understanding of product safety profiles. Evolving safety regulations and increasing case volumes call for a new path forward that is sustainable and enhances public health. While there is no question that ICSRs are a crucial component of safety surveillance, is there management for purpose in a modern ecosystem?
This initiative aims to embark on that path with a conceptual ICSR management model that could mitigate duplication and replication, allow ecosystem stakeholders to access the latest source of truth on demand, facilitate more meaningful safety analysis and interpretation, and ultimately enable a real-time learning healthcare system to improve patient safety and health outcomes.
The Modernizing ICSR Management initiative is focused on three initial components to capture the breadth of the current state problem and demonstrate the feasibility and potential value of a new operating model.
- Evidence of Burden on the Ecosystem – Extending the research article “Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks” with additional documentation of the current state’s disadvantages to the patient and ecosystem.
- Case for Change – Partnering with key stakeholders to discuss and document the fragmented and inefficient current state, the potential benefits of the envisioned future state, and a blueprint for a new option.
- Proof of Concept – Developing a simulation showcasing the proposal of a new conceptual model’s key elements and benefits to address replication from multiple perspectives in the end-to-end ICSR process. The goal of the proof of concept will be to demonstrate that such a model is feasible for solving the existing pain points.
Benefits
The primary benefit of initial solutions is to foster conversations between stakeholders with reasons and ideas to change the current state of ICSR management and safety data sharing. Through these efforts, the vision of a modernized future state will be explored with the following expected benefits:
- Reduced Burden and Improved Access
- Efficiencies in sponsor operations to meet regulatory requirements
- Enhanced global connectivity and decision-making for all stakeholders
- Refocused Effort on Higher-Value Activities
- Enabling a real-time learning healthcare system
- Optimization of PV resources to refocus effort on higher-value benefit-risk activities
- Enhanced Patient Safety and Trust
- Reduced risk of delayed or inaccurate safety analysis for patients
- Earlier public release for critical safety profile information