FDA real-world evidence to be made available on Google Cloud

By | January 9, 2020

Google announced this week that it will make the U.S. Food & Drug Administration’s open-source MyStudies platform available on the Google Cloud Platform.

The goal, said Jameson Rogers, product manager at Google Cloud Healthcare & Life Sciences, is “stimulate an open ecosystem that will improve the ability of organizations to perform research that leads to better patient outcomes.

FDA’s ongoing prioritization of real-world evidence means that “drug and device organizations are increasingly looking to incorporate patient-generated data into regulatory submissions for new products and treatment indications,” as Rogers explained in a blog post.

To help researchers manage and submit that vast and disparate data, in a secure and compliant manner, FDA developed the open-source MyStudies – a platform aimed at helping drug, biologic and device organizations with the collecting and reporting of real-world data for regulatory submissions.

Rogers said Google Cloud is working to expand the MyStudies platform with new security and configurable privacy controls, offering the the ability for research organizations to detect and personally identifying information.

That means, he said, that “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.”

This in turn will “allow a research organization to select which of its researchers and clinicians are able to access what data, and to help optimize the use of that data as directed by participants,” said Rogers. “By leveraging Google Cloud as the underlying infrastructure for their FDA MyStudies deployments, organizations will have more safeguards in the ownership and management of data in their studies.”

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As part of the initiative, Google will bring MyHeart Counts, a cardiovascular research study run by Stanford University, onto the FDA’s platform. So far, that project has enrolled more than 60,000 participants and enabled deeper understanding of the feasibility of conducting large-scale, smartphone-based clinical trials, Rogers notes.

“Once enrolled, participants are asked survey questions related to their health and physical activity,” he explained. “Participants may allow MyHeart Counts to collect physical activity data from their phone and other wearable devices. If participants are physically able, they will be asked to perform a 6-minute walk test, then enter information about risk factors and blood tests, which is used to determine a cardiovascular risk score.”

Until now, however, those participants were all iOS users: MyHeart Counts was launched in 2015 as part of the first groups of iOS research apps. But by enabling its availability through MyStudies, Google Cloud will help researchers expand their insights by enabling enrollment of both Android and iOS users.

“Consistent with our obligations under the 21st Century Cures Act, FDA engages in public-private demonstration projects to advance the regulatory science around real-world evidence,” explained Dr. David Martin, associate director for real-world evidence analytics at FDA’s Office of Medical Policy. “The Patient Centered Outcomes Research Trust Fund investment that launched FDA MyStudies is a step toward this goal.”

While FDA MyStudies is publicly available, “it requires professional expertise and time to progress from open-source resources to deployment of a new re-branded platform,” he said. “Google Cloud is taking these resources and creating a click-to-deploy option linked to additional health data management and analytics.”

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“MyHeart Counts and digital apps like it allow experts to connect directly to patients in a way that’s more immediate and more extensive, through direct, sensor-based measurement collection,” said Euan Ashley, professor of medicine, of genetics and of biomedical data science at Stanford. “Google Cloud’s support of these efforts not only helps researchers organize and deploy important research programs faster and more reliably, but ultimately will help patients and doctors notice health issues early, so they can address them sooner.”

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