A new coalition of real-world data and analytics organizations will advance policies to support regulatory use of real-world evidence. The FDA comments on the use of RWE in two sessions at the annual BIO meeting.
IN THIS ISSUE A new coalition of real-world data and analytics organizations will advance policies to support regulatory use of real-world evidence. The FDA comments on the use of RWE in two sessions at the annual BIO meeting.
The RWE Alliance, whose founding members include Flatiron Health, Aetion, IQVIA, Syapse and Tempus, announced its formation and its intent to engage with the FDA and Congress to advocate for policies that advance the use of RWE in regulatory decision making and benefit patients, including to:
Advance FDA’s RWE Framework
Encourage use of RWE to better understand treatment effects in underrepresented populations
Enhance opportunities for RWE organizations to consult with FDA
Increase communication on the generation and use of RWE
In a town hall meeting, CDER Director Patrizia Cavazzoni noted FDA’s confidence in using RWE to characterize safety, as well as the potential for RWE to fill in data gaps on subpopulations, but noted hurdles still exist in using RWD and RWE to characterize effectiveness.
Acting FDA Commissioner Janet Woodcock was asked in a fireside chat about her thoughts on the future of RWE, to which she responded that the FDA has and will continue to use RWE but has a “real bridge to cross” with regards to determining causal inference between interventions and patient outcomes.
Flatiron’s research highlights important applications, insights and impact of real-world data in discovery, therapeutic development and cancer care at ASCO 2021– with one critical goal in mind – to improve lives by learning from the experience of every patient with cancer.
EVENTS
July 14
Demystifying AI in the Life Sciences Industry: What Regulatory, Quality and Compliance Professionals Need to Know
Join this webinar to learn more about, and how to overcome, the barriers to AI implementation in a life sciences regulatory environment.
FDA-Project Data Share (PDS) Symposia: Data sharing & reuse of oncology clinical research data – policies and practices that enable greater access and utilization of patient level data
This webinar will focus on building a consensus around methods, policies, and a clear understanding of actions as it relates to sharing clinical trial data.
