How the FDA is Embracing Real-World Data

FDAIn 2016, the FDA and Flatiron Health started a collaboration to learn from Real-World clinical data. That Real-World Data (RWD) originates from the health records of cancer patients that Flatiron analyses.

Flatiron collects data on what medications a patient has taken, and how they have responded to them.

The goal of the collaboration is to unlock data from US electronic health records. US EHRs tend to be organised to help insurance companies, rather than ordered by say, the rate at which a tumour is shrinking. This organisational structure makes the data difficult to access for use within a study.

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Zach Weinberg, left, and Nat Turner, the founders of Flatiron Health.

The first results from this collaboration were presented at the American Society of Clinical Oncology annual conference earlier this month. This conference presentation was a first for Flatiron. This year 14 studies presented included data from the company’s database.

One of the first studies of the collaboration looked into how PD-1 checkpoint inhibitors are being used in non-small-cell lung cancer patients. PD-1 checkpoint inhibitors are a type of cancer immunotherapy drug.

The research study sheds new light on how these drugs are used. Findings suggest that medicines are not used quite like how they are approved by the FDA. This could make a huge difference in the effectivity of treatments.
This information is crucial for the FDA to know. When drugs are used in different ways than how they are approved, patient outcomes may differ from what physicians might expect.

Dr. Sean Khozin is one of the authors on the study and a senior medical officer at the FDA. He said that Flatiron is just one of many companies the agency is working with to check out how alternative sources of data can be used to better inform the agency. This is a big step, and a brilliant sign that the regulatory authorities world-wide are truly embracing RWD and its potential.

FDAFlatiron’s research process is similar to a registry trial. The advantage is that data from over the years is already available from within their databases, so trials are shorter.

Going forward, data from this collaboration will help to fine-tune cancer treatments. For example; if the patients on Flatiron’s database that are using the checkpoint inhibitors tend to get better results when they’re older, the FDA could change guidelines to recommend that doctors put older patient on that course of treatment, and work with other treatments for younger patient groups.

We look forward to seeing more from Flatiron Health’s collaboration with the FDA; watch this space for further reports!