FDA Taps Google Cloud for Real World Evidence Use

With industry’s growing use of real-world evidence in drug development and discovery, the Food and Drug Administration is looking to encourage further use of real-world data by having its open-source MyStudies platform for regulatory submissions on the Google Cloud Platform.

“Because of the FDA’s focus on real-world evidence, drug and device organizations are increasingly looking to incorporate patient-generated data into regulatory submissions for new products and treatment indications,” noted Jameson Rogers, product manager at Google Cloud Healthcare & Life Sciences. But, he added, that industry lacked regulatory compliant “mobile technologies or methodologies to help collect, store and submit this kind of data” until recently. 

FDA launched its open-source technology platform — the MyStudies app — in November 2018 for RWD collection to improve efficiency in and help lower the cost of product development. Former FDA commissioner, Scott Gottlieb, said at that time that the new MyStudies app “will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology.” 

The system has been available to product developers to configure and create their own branded apps that can be used not just in traditional clinical trials, but also in RWE studies and registries. 

And now, Google Cloud is “working to expand on the FDA’s MyStutdies platform with built-in security and configurable privacy controls, and the ability for research organizations to automatically detect and protect personally identifying information,” said Rogers. “When an organization deploys FDA MyStudies on Google Cloud, a unique and logically isolated instance of the platform is created that only that organization and its delegates are authorized to access.”

With the instance of the platform that is created, a research organization can pick and choose the researchers and clinicians that will have access to what data while optimizing the use of that data. Having Google Cloud serve as the underlying infrastructure in MyStudies deployments offers additional safeguards in data ownership and data management while conducting studies. 

Industry’s increasing use of patient health data in product development has come with the digitization of health care, underpinned by the value-based care shift. FDA's partnership with Google Cloud is intended to improve health outcomes by helping study sponsors leverage high-quality RWE collection and improve efficiency in clinical trials with the additional set of capabilities, such as a "click-to-deploy" option later this year to reduce complexity.

“FDA MyStudies is publicly available, but it requires professional expertise and time to progress from open-source resources to deployment of a new re-branded platform,” said David Martin, associate director for RWE analytics at the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research. “As a company may do, Google Cloud is taking these resources and creating a click-to-deploy option linked to additional health data management and analytics.”

The MyStudies app supports the recent patient-focused drug development (PFDD) trend, also.

Rogers added that “study sponsors have already leveraged the FDA’s existing MyStudies platform to build branded and customized mobile applications to administer questionnaires that assess patient-reported outcomes, patient reports of prescription and over-the-counter medication use, trial medication diaries and other patient experience data.” Running the MyStudies app on Google Cloud will also allow companies to make use of other offerings. 

FDA began pushing toward greater use of RWE along with industry and others like Google in recent years, following the launch of CDER’s RWE Program in 2018. FDA has released a series of PFDD guidance documents and plans to continue exploring the potential for RWE to inform regulatory decision-making under its initiatives — both of which are mandated by the 21st Century Cures Act of 2016. It released at least one draft guidance on submitting documents using real-world data and RWE for drugs and biologics but plans on releasing additional RWE guidance.  

“Google Cloud will continue investing in MyStudies to bring general improvements to the platform, expand the number of supported assessments and enable integration with downstream analytics and visualization tools,” Rogers further noted.