Quality & Governance News

FDA Makes Real-World Data Available on Google Cloud Platform

The FDA’s open-source MyStudies platform is now available on Google Cloud, further supporting the use of real-world data in medical research.

FDA makes real-world data available on Google Cloud

Source: Thinkstock

By Jessica Kent

- The FDA’s MyStudies platform, a tool that aims to collect real-world data to improve clinical trials and advance medical research, is now available on Google Cloud Platform.

Launched in November 2018, the MyStudies open-source technology platform supports drug, biologic, and device organizations as they collect and report real-world data for regulatory submissions.

Google Cloud is working to expand the MyStudies platform with built-in security and configurable privacy controls, and the ability for research organizations to automatically detect and protect personally identifying information. When an organization deploys FDA MyStudies on Google Cloud, an isolated instance of the platform is created that only the organization and its delegates are able to access.

These technologies will allow a research organization to select which researchers and clinicians can access what data and help optimize the use of that data as directed by participants.

“By building on the platform developed by the FDA, we hope to stimulate an open ecosystem that will improve the ability of organizations to perform research that leads to better patient outcomes,” Jameson Rogers, PhD, Product Manager, Google Cloud Healthcare & Life Sciences wrote in a recent blog post.

“This collaboration continues our long history of open-source work, and our commitment to producing easy-to-use tools that serve the healthcare and life sciences community.”

The MyStudies platform includes important features that support patient accessibility and privacy.

Additionally, study sponsors have already used the FDA’s existing MyStudies platform to build branded and customized mobile applications to administer questionnaires that evaluate patient-reported outcomes, patient reports of prescription and over-the-counter medication use, trial medication diaries, and other patient experience data. By supporting MyStudies on Google Cloud, study sponsors can easily benefit from the platform and leverage this data.

Google Cloud is also equipping the MyStudies platform with an additional set of capabilities that will reduce complexity and overhead. A “click-to-deploy” option, available in Google Cloud Marketplace later this year, will benefit study designers who don’t want to build a compliant environment from scratch.

Using this option, a private MyStudies instance is built from the open-source repository. That instance is then configured following best practices to operate with selected Google Cloud services, allowing research groups to establish their own preconfigured instance of the FDA’s MyStudies platform in minutes.

“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. The Patient Centered Outcomes Research Trust Fund investment that launched FDA MyStudies is a step toward this goal,” said David Martin, MD, associate director for Real-World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. 

“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. 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.”

Supporting FDA’s MyStudies platform on Google Cloud will also advance Stanford University’s MyHeart Counts study. The open enrollment study aims to collect physical activity data from participants’ phones and other wearable devices, as well as answers to survey questions about individuals’ health and physical activity.

The current version of MyHeart Counts is only available on iOS devices. By using MyStudies on Google Cloud, researchers will be able to conduct a multi-arm, randomized controlled trial that runs on both Android and iOS devices. Additional improvements to the MyStudies platform will allow researchers to configure and deploy studies in days rather than months, without needing to develop software.

“In this digital era where everyone uses a smartphone, hosting a trial on an app lets us tap into a huge population. We are grateful for Google’s support because it enables us to expand our reach to include Android participants in addition to iOS, and incorporate an open-enrollment randomized controlled trial into a mobile application for the first time,” said Professor Euan Ashley, MBChB, DPhil, professor of medicine, of genetics and of biomedical data science at Stanford.

“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. 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.”

By supporting FDA’s MyStudies on Google Cloud, stakeholders are further advancing the use of real-world data in medicine and healthcare research.

“In the spirit of our commitment to healthcare and open-source, 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 concluded.