Pivotal Study Validates Real-World Mortality Endpoint for Oncology Research

NEW YORK, NY

Today, Flatiron Health, a market leader in the curation of regulatory-grade real-world data for cancer research and real-world evidence (RWE) generation, announced the publication of a pivotal study validating the quality of Flatiron’s mortality endpoint and illustrating the potential impact for research conducted with contemporary real-world datasets.  

Published in collaboration with Genentech in Health Services Research, ”Development and Validation of a High-Quality Composite Real-World Mortality Endpoint” establishes a new standard for researchers attempting to leverage RWE to elucidate the outcomes of cancer patients treated outside of the clinical trial setting.

A key goal of oncology research is to improve patient survival. However, oncology investigators have lacked access to a national, research-grade mortality dataset with the recency and scale needed for contemporary survival analyses. Consequently, in the prospective research setting, clinical trial investigators are forced to methodically collect date of death in every clinical trial, diverting resources from other critical research questions, like defining the safety profile of a new drug. Flatiron Health has generated a mortality dataset that reliably answers both sides of this equation.

The published study details how investigators created a novel real-world mortality endpoint using multiple data sources to supplement Flatiron’s curated electronic health record data, collected from the company’s network of over 2,500 oncology clinicians. Benchmarked against “gold standard” mortality data from the U.S. National Death Index, the Flatiron mortality endpoint demonstrates high completeness and agreement across a range of tumor types. As the study authors conclude, “The high quality and recency of this variable makes it suitable for evaluating outcomes in oncology using retrospective and prospective study designs that leverage RWE.”  Additionally, use of the dataset could potentially reduce the time and cost associated with conducting follow-up analyses in clinical trials.

Ultimately, the development and validation of novel endpoints based on de-identified real-world data is critically needed to enable RWE to meet regulatory data standards. As regulatory applications of real-world data accelerate through legislation like the 21st Century Cures Act, Flatiron is committed to investing in research that helps establish new quality standards for industry-wide use. The publication of the mortality endpoint is the first in a series of novel real-world endpoints that Flatiron is currently developing.

“With this mortality variable incorporated into Flatiron’s datasets, researchers can now conduct analyses that traditionally would have only been possible through a traditional prospective clinical trial, or would have been infeasible to conduct altogether.” said Dr. Amy Abernethy, chief scientific officer, chief medical officer and SVP, oncology, Flatiron Health. “Our goal is to advance the national conversation around the use of RWE for high-impact research by working across the industry with partners like the Food & Drug Administration and the National Cancer Institute to define and implement new quality standards.”

The authors of “Development and Validation of a High-Quality Composite Real-World Mortality Endpoint” published today in Health Services Research include: Melissa D. Curtis, Sandra D. Griffith, Melisa Tucker, Michael D. Taylor, William B. Capra, Gillis Carrigan, Ben Holzman, Aracelis Z. Torres, Paul You, Brandon Arnieri and Amy P. Abernethy.

Location:
NEW YORK, NY, May 14, 2018