Continued Support for the Future of Benefit-Risk Assessment

Continued Support for the Future of Benefit-Risk Assessment

01.30.12 | By Kate Connors

Today, PhRMA announced that we are transferring the future development of our benefit-risk assessment framework to the Centre for Innovation in Regulatory Science. As our press release stresses, this move is intended to further the framework - which we developed over the course of six years from an analytical model to a functional pilot program - so that the principles can be more broadly available for use by all stakeholders, from industry to regulators and healthcare providers.

Stepping back a bit, though, and looking at the whole spectrum of research, this project really demonstrates the progression of science as well as our commitment to new tools that can help us make better use of that science.

From patient-reported outcomes to biomarkers to benefit-risk assessments, we are moving forward in terms of evaluating our clinical understanding of medicines, both during development and in the post-market phase. It's exciting to see these advancements, and it will take true collaboration among industry, regulators and others in order to ensure the adoption of these tools in a way that furthers patient care.

And as the evolving science allows us to continue to make progress in the world of rare diseases and other unmet medical needs, tools like structured benefit-risk assessments will become increasingly more important and informative.

It's also worth noting that as excited as we are about this project, we are just as excited about the future developments for benefit-risk assessments at FDA. In the PDUFA-V performance goals letter, the agency spells out plans to create its own systematic approach to benefit-risk. Such a framework would ensure a more consistent and predictable review process and enhanced transparency, allowing improved access to innovative new medicines as well as increased public understanding of their benefits and risks.

As always, collaboration is key - and we believe that our partnership with CIRS represents an important step toward making a standardized approach to benefit-risk assessment a reality.

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