Flatiron’s former CMO & CSO, Amy Abernethy, and Dr. Rick Pazdur of the FDA discuss the agency’s engagement with real-world evidence, the path forward for RWE, and the future of cancer care at the 2018 Flatiron Research Summit.
It all starts at the point of care.
Flatiron real-world evidence is derived primarily from the EHRs of over 280 community clinics and academic institutions at over 800 geographically diverse sites of care.
Together, our partners help us to form the largest and highest quality source for real-world evidence in oncology – including both structured and unstructured data, and longitudinal clinic data with tumor specific models that evolve with the standard of care.
Powering new research with real-world endpoints.
Historically, the idiosyncrasies of real-world data have kept the promise of regulatory-grade real-world evidence out of reach.
Today, with Flatiron’s technology, researchers across the industry are using RWE to develop breakthroughs like the external control arm. These advances hold the potential to transform the way research is conducted – opening the door for faster approvals and increasing the breadth of questions researchers can address.
Revealing new insights with linked clinical and genomic data.
This first-in-class, real-world data source integrates Foundation Medicine’s next-generation tumor sequencing data with Flatiron’s longitudinal treatment and outcomes data captured from the EHR.
With the Clinico-Genomic Database, researchers can conduct outcomes studies in biomarker-defined populations, discover novel targets and more effectively design clinical trials.
Designed to meet the most rigorous quality standards for RWE.
Patent-pending abstraction process carefully augments human expertise with machine learning and other technology-enabled optimizations.
Data Quality Control
Thorough quality assurance and complete data provenance for every data point generated.
Active collaborations with the FDA and NCI to define the requirements and uses for regulatory grade RWE.
Bristol-Myers Squibb recently submitted an analysis in which we (our company) created a synthetic control arm ... supporting a regulatory filing the FDA accepted. The synthetic control arm saved us two to three years where, in most cases, traditional trial paths may have caused a significant delay in filing.
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Each month, we share newly published research powered by Flatiron real-world evidence.