A new industry coalition launched on Thursday, with the purpose of innovating and expanding the use of real-world evidence to inform and support regulatory and policy decisions.
WHY IT MATTERS
The five founding members of the RWE Alliance are Aetion, Flatiron Health, IQVIA, Syapse, and Tempus – which each have different areas of focus, but all traffic in a variety of real-world information sources to help various stakeholders improve care and outcomes.
“We are a coalition of real-world data and analytics organizations with a common interest in harnessing the power of real-world evidence to inform regulatory decision making to improve patients’ lives,” the companies said on the RWE Alliance.
The goal, they say, is to more closely engage with regulators and policymakers at the U.S. Food and Drug Administration and on Capitol Hill to help advocate for more advanced use of data derived from electronic health records, insurance claims, product and disease registries, connected devices, wearables, apps and other sources from outside of clinical trials.
“Our members have deep knowledge and experience working with healthcare data across disease areas and patient populations,” the companies said. “The RWE Alliance will bring these collective insights to bear as we engage with leaders at FDA and in Congress in support of RWE policy.”
The alliance will also work alongside patient groups, pharma companies, medical device manufacturers and other key stakeholders to support broader efforts around the use of RWE, which members say helps regulators, developers and providers have a deeper understanding of medical product safety and efficacy.
That, in turn, enables faster access to new treatment options, they say, and helps better characterize treatment effects, including in underrepresented populations.
THE LARGER TREND
RWE Alliance notes that policymakers are increasingly attuned to the value of RWE as new medicines, vaccines, devices and approaches to public health are developed. The landmark 21st Century Cures, for example, has a provision that directs FDA to launch a program in the next two years to assess uses of RWE in drug development and approval processes.
The FDA has already been exploring new approaches to its own decision making, with a new framework for its RWE Program and an array of RWE-focused research collaborations.
(This past year, the agency worked with Google Cloud to enable easier access to RWE, making the agency’s open-source MyStudies platform available for research into new medications, devices and more.)
RWE Alliance says it plans to “contribute to these and similar efforts, and to engage with FDA on its 2021 Guidance Agenda and 2022 user fee authorization,” among other activities.
Alliance companies have already been working with FDA on several RWE initiatives.
In 2019, Syapse partnered with the agency to study regulatory use of real-world evidence – specifically how secure patient data can be better put to work in the development of precision medicine and oncology treatments.
And a year ago, Aetion – which just this month landed $110 million in its Series C round as it looks to expand worldwide – launched a project with FDA to use real-world patient information for answers around COVID-19 risk factors, treatments and population health trends.
“Events of the past year have made clear that evidence derived from RWD is critical to assessing the safety, effectiveness, and value of drugs, vaccines, devices, and diagnostics,” said Aetion CEO Carolyn Magill in a statement announcing RWE Alliance.
ON THE RECORD
“The diversity of RWD and RWE use cases has expanded in breadth and depth in recent years,” said Dr. Michael Vasconcelles, chief medical officer at Flatiron Health, in a statement. “Now is the right time for those with the technical and scientific expertise in RWD and RWE to come together and work with other stakeholders to advance the policy frameworks, guidelines and standards needed to provide critical clinical insights and support rigorous, evidence-based decisions.”
Twitter: @MikeMiliardHITN
Email the writer: [email protected]
Healthcare IT News is a HIMSS publication.
Source: Read Full Article
