You can rely on our experienced team to help you navigate the ever-evolving landscape of benefit-risk assessment and meet the requirements of regulatory and reimbursement stakeholders worldwide. Our integrated team of cross-functional experts can provide you with the guidance you need to synthesize, summarize, and confidently act on the relevant evidence for your product. We’ll help you build consensus within your organization to achieve a common understanding, increased transparency, and improved communication about your product’s benefit-risk profile.
Benefit-Risk Assessment
Strengthening Benefit-Risk Assessments Early in Product Development
Conducting credible benefit-risk assessments presents unique challenges because the data on risks and benefits are not usually measured together in the same studies or study populations and are not often gathered in a real-world setting. Additionally, these measurements might not be collected in the same way in both short and long-term studies or using the same units.
By engaging with our benefit-risk assessment team early in the development lifecycle, we can help you account for these challenges and avoid costly re-work and lost time at a critical stage in your product’s development process—while helping you position your product with strong benefit-risk evidence that resonates with your audience.
A Structured Benefit-Risk Assessment Approach Tailored to Your Needs
Our teams have the benefit-risk assessment expertise essential for developing a robust plan individualized to your needs. Once we have helped you develop a complete picture of your data, we can help you identify gaps to inform a strategy for possible new studies to include in your clinical development program and clarify appropriate post-approval activities.
Our benefit-risk assessment services include:
- Understanding how a structured approach can improve your evidence generation and communication strategy
- Incorporating patient and/or provider preferences and patient perspectives
- Selecting the best metrics for measuring key benefits and risks that will resonate with providers and patients post-approval
- Identifying the best analytic approach for synthesizing clinical trial and/or real-world data
- Implementing additional risk minimization measures, and studies to evaluate their effectiveness
- Initiating postmarketing safety studies and/or comparative effectiveness studies
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Vice President, Epidemiology
Vice President and Senior Economist , Health Preference Assessment
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Vice President, Patient-Centered Outcomes Assessment
Frequently asked questions about Benefit-Risk Assessment
What is a benefit-risk assessment, and why is it important?
A benefit-risk assessment helps determine if the benefits of a product outweigh its potential risks. It's crucial for regulatory approval, reimbursement decisions, and product adoption by healthcare providers and patients.
How do you support a benefit-risk assessment for my product?
Our team can provide expert training, consultation and/or implementation of based on a structured framework tailored to your needs, incorporating clinical trial and real-world data, as well as patient and provider preferences, to build a comprehensive benefit-risk profile.
What role do patient and provider preferences play in the assessment?
Incorporating patient and provider perspectives ensures that the benefit-risk assessment reflects real-world concerns, improving the relevance and effectiveness of the communication strategy post-approval.
Why should I initiate a benefit-risk assessment early in product development?
Early engagement helps address potential challenges early, identify data gaps, and create a solid foundation for the product’s development, minimizing costly re-work and delays later on.
How does your team help with data gaps during the benefit-risk assessment process?
Our experts help identify data gaps and develop strategies for new studies or additional risk mitigation measures that can be included in the clinical development program or post-approval activities.
What are the challenges of conducting a benefit-risk assessment?
Benefit-risk assessments are challenging due to the complexity of data collection, variability between short-term and long-term studies, and differences in measurement units or study populations.
How do post-marketing studies contribute to benefit-risk assessment?
Post-marketing safety studies and comparative effectiveness studies are critical to evaluate the long-term benefits and risks, as well as to ensure that risk minimization strategies are effective.
How does a benefit-risk assessment help in regulatory and reimbursement decisions?
A well-conducted benefit-risk assessment provides the evidence needed to demonstrate your product's safety and efficacy, helping you gain regulatory approval and secure reimbursement from payers.