FDA Unveils MyStudies App with Aim to Collect Real-World Data

^{The FDA developed the MyStudies app to improve drug development, health outcomes and patient engagement.}

The U.S. Food and Drug Administration yesterday unveiled a new mobile technology, the MyStudies app, for capturing real-world patient data.

FDA Commissioner Scott Gottlieb, M.D., said the digital tool and its resultant real-world evidence could improve the quality the regulator’s decision making and safety monitoring regarding medications.

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“This will ultimately help us achieve better outcomes and safer and more efficient use of expensive technology,” Gottlieb said in a statement. “This digital platform enables developers to adapt our technology to advance new ways to access and use data collected directly from patients — with the necessary controls in place to ensure patient privacy.”

The FDA-developed MyStudies app comes at a time when the healthcare and research worlds are closely watching how the agency handles new technologies, including those used to measure the efficacy of drugs and devices and those digital health innovations that the FDA oversees. Just last week, for instance, the New England Journal of Medicine published a perspective arguing that the legal framework that governs drug and device approvals would benefit from a digital health-minded overhaul.

The MyStudies app leverages patient-generated data, electronic health records, claims and billing data and other sources of information to buttress clinical trials, observational studies, pragmatic trials and registries, according to the FDA.

FDA officials worked with Kaiser Permanente to pilot a study measuring the functionality and engagement of the MyStudies app, which produced results that moved the agency to release open-source code and other documents that could enable researchers and developers to customize the program and contribute new data. The FDA said this tool ensures compliance with regulations and data standards.

MyStudies can be configured for various therapeutic areas and patient outcomes, which the FDA said, “reduces software development hurdles for non-FDA users.” Its design also supports multi-site trials across a secure digital environment.

In the future, the FDA plans to release MyStudies app code built for Apple ResearchKit and Google’s Android system.

“Better capture of real-world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety and help lower the cost of product development,” Gottlieb said. “Our hope is that the collection of more real-world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring.”

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