The impact of a universal standard for generating real-world evidence could carry significant benefits, according to an eyeforpharma article, but how could companies formulate such a standard?
“This is a work in progress, but when you think about data quality, it must be fit for purpose and so depending on the individual data field that we are talking about, the way to validate quality could be different as well,” Roche/Genentech’s Jacqueline Law says.
Flatiron Health Vice President of Life Sciences Shane Woods says there exists a need for robust criteria that envelopes RWE generation.
“We have a proprietary method that includes both technology and skilled clinicians based in the U.S. in which we abstract, normalize and de-identify data from the EHR,” Woods said. “Our technical approach and centralized oversight abstraction processes ensure that our data are of high quality and that regulators can trust in our methodology and ultimately the product so that findings from our datasets can be used to inform regulatory decisions.”