The Role of Real-World Evidence in Regulatory Decision Making

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.

Explore more real-world evidence resources



A collaboration with the FDA: How Flatiron real-world evidence provides actionable insights

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Generating regulatory-grade real-world evidence: A data quality checklist

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The Clinico-Genomic Database: Advancing personalized medicine

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Above: The reach of Flatiron's geographically diverse group of community clinics and academic research centers

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.

Adapted from Bartlett C et al. Concordance of real world progression free survival (PFS) on endocrine therapy as first line treatment for metastatic breast cancer using electronic health record with proper quality control versus conventional PFS from a phase 3 trial. San Antonio Breast Cancer Symposium. December 5-9, 2017; San Antonio, Texas.

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.

Adapted from Singal G et. al. Identification of resistance mechanisms to EGFR treatment in the real world using a clinicogenomic database. AACR Annual Meeting. April 14-18, 2018; Chicago, IL.

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.

Technology-Enabled Abstraction

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.

Regulatory Collaborations

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.

Marisa Co — Vice President, R&D Analytics, Bristol-Myers Squibb
DATAx interview, December 11, 2018

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