The Food and Drug Administration is partnering with a health analytics company to gather and analyze real world evidence on immune checkpoint inhibitors for the treatment of advanced non–small-cell lung cancer.
The partnership, which will eventually extend to the study of other cancer types, is designed “to determine how real world evidence derived from deidentified, HIPAA-compliant patient data captured outside of clinical trials can provide new insights into the safety and effectiveness of emerging anticancer therapies,” the company, Flatiron Health, said in a written statement.
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“Flatiron will be responsible for collecting all of the electronic health records and processing them using [their] proprietary technology abstraction method. The FDA will be responsible for analysis, although this is intended to be a collaborative process with FDA and Flatiron working together on the analysis,” Amy Abernethy, MD, chief medical officer and senior vice president, oncology, Flatiron Health, said in an interview.
A unique advantage of this study is that it will span multiple payers, geographies, and demographics unlike previous studies and trials that consist largely of white patients living in urban settings who rely on Medicare or Medicaid to cover health care costs, she said.
“The goal is to generate a data set that represents the broad story of real people, from across the country, who are being treated with immuno-oncology agents for lung cancer,” said Dr. Abernethy.
Immune checkpoint inhibitors are the first focus because “things are changing so fast that clinical trials cannot always fill in the details,” Dr. Abernethy said. “It is not currently clear how providers are treating advanced non–small-cell lung cancer patients with immune therapies and how immune therapies are used in relation to other newly approved targeted therapies or traditional chemotherapy.”
This project and others will help define how real world evidence is best used, and whether it will be of adequate quality to meet a regulatory standard.
“Maybe the FDA finds that real world evidence is only applicable in certain settings or to answer certain questions. This might restrict the potential for Flatiron products, but ultimately helps to define where real world evidence is best used,” Dr. Abernethy said.