Evidence-Based Analysis
The Power of Fact
This first step of a successful REMS design is evidence-based analysis that may include:
- RxFMEA®
- Benefit-risk analysis frameworks and workshops
- Strategy tradeoff analysis for identified stakeholders
RxFMEA®
ParagonRx has developed a proprietary approach to risk, based on an FDA-approved approach. Our adaptation of failure modes and effect analysis (FMEA), called RxFMEA®, is a bottom-up assessment to identify key causes of suboptimal outcomes and to prioritize those behaviors that are most important to address.
Leveraging your cross-functional team, we identify and target interventions that directly mitigate the most frequent risks that are amenable to intervention. When regulators see this transparent process, negotiation can be based on facts and evidence, rather than on opinion and speculation.
Benefit-Risk Analysis
Proven approach to assess each product’s risk, which risks are adequately addressed by labeling, and which risks require interventions beyond labeling
In a collaborative setting, and in the context of the product benefits, the team is guided through an exercise to delineate identified and potential risks and, for each, the labeling language, interventions, assessment measures, and potential contingencies.
Strategy Tradeoff Analysis
Following a benefit-risk analysis, or based on prior work by the team, a further assessment is conducted to identify the following:
- Is there a discrete profile of higher risk?
- Where in the care delivery process do risks manifest?
- Where in the care delivery process can risks be most effectively minimized in the least burdensome way and by whom?
- What will be the FDA expectations? How can we address those requirements?
These findings help define boundary conditions, targets and tradeoffs that help inform REMS strategy, planning and design activities
The Advantage
Actions that mitigate identified risks, whether formalized in a REMS or other program, encourage prescribing the right product, for the right patient, and the right time, with the right administration. This approach contributes to creating improved outcomes and greater recognition of your product's value.