“Healthcare technology and services specialist Flatiron Health and the U.S. Food and Drug Administration (FDA) announced a two-year renewal and expansion of their research collaboration agreement, the Information Exchange and Data Transformation (INFORMED) program. The goal of the partnership is to evaluate how real-world evidence (RWE), derived from de-identified patient datasets curated from electronic health records (EHR), can help support regulatory decision-making.”
“WHY IT MATTERS
The two bodies will evaluate real-world cancer populations that are typically underrepresented in clinical trials, as well as focus on topics related to the use of RWE in regulatory decision-making.”
“These include validation of reliable real-world clinical endpoints, exploration of innovative applications such as real-world control arms, collaboration on…” Read the full article here.
Source: FDA, Flatiron Health expand cancer research partnership – By Nathan Eddy, February 25, 2019. HealthcareITNews.