To identify industry best practices in safety signaling and gain clarity on future state capabilities that organizations are prioritizing to navigate the rapidly evolving PV landscape.
Method
A comprehensive survey was designed to capture detailed information on safety organizations' post-market signaling processes and capabilities. The survey data collected from was synthesized to identify and document industry best practices.
Results
The survey was distributed to 15 organizations, with responses received from 7 organizations. The collected data was then synthesized to identify and document industry best practices across the following focus areas: Quantitative Review & Product Schedules, Qualitative Review of ICSRs as part of Signaling Activities, External Data Sources, and General Processes.
Several key findings and trends emerged from this benchmarking study including:
Quantitative and Qualitative Review: All organizations use a mix of both qualitative and quantitative review methods. While frequency and methodology of quantitative review varied slightly across organizations, there was consistent review criteria, and a similar approach leveraged for qualitative review.
External Data Sources: The most common external databases utilized for signaling are FAERS, VAERS, and EVDAS, with organizations diverging in their approach to signaling for all products or leveraging a risk-based approach.
Literature review is typically performed weekly, with signals being recorded in signal management tools
RMP Topics: Some companies track RMP topics categorized as missing information in the signaling tool or other standard tools
Conclusion
In the rapidly evolving biopharma industry, PV organizations face numerous challenges in ensuring patient safety, addressing cost pressures, and maintaining regulatory compliance. This benchmarking study on safety signaling has provided valuable insights into the current practices and future priorities of biopharma companies. The findings highlight the prevalent use of both quantitative and qualitative review methods, the reliance on key external data sources, and the varied approaches to signal management.
Additionally, the exercise has identified several industry challenges that organizations face in their safety signaling efforts. These include the need for standardized methodologies, the integration of diverse data sources, and the efficient management of large volumes of safety data. Addressing these challenges is crucial for enhancing the effectiveness of PV activities.
By understanding these best practices and challenges, organizations can better optimize their safety signaling processes, adopt industry-leading strategies, and effectively navigate the evolving PV landscape. This benchmarking study serves as an industry reference for biopharma companies aiming to enhance their drug safety operations and ensure patient safety.
