FDA releases open-source app to collect patient-reported data

The Food and Drug Administration launched a new app Wednesday to gather data for clinical trials and other research directly from patients.

The FDA released the MyStudies app source code to the public, allowing developers and researchers to tailor the app to suit their research needs. The agency designed the app to facilitate the use of real-world data in research.

Patients can submit real-world data to the app via their mobile devices. Researchers can then link those data to other electronic health information. The goal is to improve drug development.

"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," FDA Commissioner Dr. Scott Gottlieb said in a statement. "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."

Researchers ran a pilot study of the app at Kaiser Permanente Washington Health Research Network. They used the app to study medication use and outcomes among pregnant women. They concluded that MyStudies has the technical, scientific and governance procedures necessary for broader use in clinical research.

As the app is further developed, they expect it to gain greater capabilities, including a more user-friendly design and integration with more data sources.

Other organizations also are turning to patients and their mobile devices to gather patient-generated data. Apple and Stanford have been collecting data from patients since November for the Apple Heart Study. Researchers hope to determine whether Apple Watches can accurately detect atrial fibrillation. More than 400,000 participants have enrolled in the study, which will conclude in 2019.

The MyStudies app runs on both iOS and Android mobile operating systems. Both Apple and Google offer open-souce tool for building research apps. Some of these apps ask patients to track and measure their symptoms. Novartis has an app based on Apple's development tools to gather patient-reported data on eye disease, which its researchers hope to use to develop new treatments.

The FDA plans to continue to develop the MyStudies app "over the next several calendar quarters," according to the agency. One new feature will let researchers send out surveys based on patients' enrollment dates. Another will let developers create survey questions that vary based on patients' answers to earlier questions.