More emphasis has been placed on aggregate safety assessments to establish a reasonably possible causal association
- Sponsors have developed processes and procedures for evaluating and assessing accumulating safety information on an ongoing basis
- Leveraging scientific expertise and medical judgment of multi-disciplinary safety management teams
- To supplement medical safety reviews of individual cases and medical monitoring of individual studies
Regulators in the US and EU support a more systematic approach
- To recognize, assess, and characterize important safety information,
- Which will inform and improve risk management
Proactive Safety Assessments to Enable Effective Risk Management
Complete elimination of safety risks will never be possible. We need proactive safety assessments to enable effective risk management. The goal is to identify, understand and manage risks so that we can deliver effective medicines to the right patients; to protect patients participating in clinical trials and after marketing, but also to save programs with favorable benefit-risk profiles for distinct patient populations.
- Patient perspective: Allow distinct patient populations to realize important health benefits of effective drugs
- Regulatory perspective: Improve the way we identify patients at higher risk so that we can better position products in the marketplace
- Sponsor perspective: Avoid premature termination of programs that show promise even in the face of important risks
We need cross-disciplinary scientific engagement: for earlier signal detection, for generating a better understanding of the accumulating data, and for context needed to decrease false alarms. The Aggregate Safety Assessment Planning (ASAP) process helps to detect, identify and characterize safety signals, but also provides context and understanding to refute false signals.