Systematic Risk Assessment for Risk-Based Monitoring
Risk Management, RMPs, and REMS
What is PrOACT-URL framework?PrOACT-URL is an acronym for Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainties, Risk tolerance, and Linked decisions. It is a generic eight-stage qualitative framework which provides structure for decision making. The European Medicines Agency (EMA) has adapted this framework for regulatory use in drug benefit-risk assessment. This adaptation is one of the results of the EMA’s Benefit-Risk Methodology Project. The goal of this project was to explore methodologies that can increase the consistency and transparency of the benefit-risk assessment for medicinal products among assessors. The objective of this project was to develop and test tools and processes for balancing multiple benefits and risks.
When would I need to use PrOACT-URL framework?A common framework is necessary for the transparent communication of the benefits and risks of a therapeutic product across disparate stakeholders. Companies should be performing a benefit-risk assessment for every product at every decision point at every stage of the product life cycle. Benefit-risk assessment should start early in the clinical development process and continue through the post-marketing timeframe.
What are the benefits of doing PrOACT-URL framework?Using the PrOACT-URL framework for benefit-risk assessment provides:
- A systematic approach to decision making and organization to the main elements of benefit-risk assessment and may aid in gaining group consensus
- Guidance for identifying the main elements to be considered in the benefit risk assessment analysis
- A common ground to facilitate communication and transparency regarding benefit-risk assessment with regulatory agencies
- The basis for further analysis of benefit-risk balance (e.g., quantitative approaches)