Dr Andrew Rut recently presented at the PV Legal Forum in Chicago on the importance of collecting and analyzing holistic safety data in order to make good decisions for individual patients needing treatments.
Disconnected systems lead to gaps and errors in the pharmacovigilance process:
• There is a lack of information at market authorization as clinical trials are necessarily conducted on small, restricted populations.
• Complex systems for capturing the adverse events experienced on marketed products limit the volume and quality of data available for analysis.
• Safety information is not aggregated across all sources, or considered in parallel with information on benefit, reducing the ability to make targeted benefit-risk assessments.
Dr Rut’s presentation discusses the challenges and explains how the use of digital tools, automation, and expert teams enables the appropriate collection, classification, and analysis of data holistically. This enables pharma to build a complete picture of the benefits and risks of medications and how they are best deployed to give optimum results for patients.