Eye on the FDA

SILVER SPRING, Md.—Late 2018 saw the U.S. Food and Drug Administration announce the MyStudies app, a new mobile technology to foster the collection of real-world evidence via patients’ mobile devices. Real-world data can be collected from a variety of sources, such as electronic health records, claims and billing activities, and product and disease registries, as well as from patient-generated data including in home-use settings, or from data gathered from other sources, such as mobile devices.

 

As part of the agency’s work to foster greater opportunities around real world evidence, the FDA partnered with Kaiser Permanente on a pilot study to measure the functionality and engagement of the MyStudies app. Based on the successful outcome of the study, the FDA released the open-source code and technical documents that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app to expand the diversity of health information available for clinical trials and studies, while directly capturing the perspective of patients. By providing the open-source code, the agency is providing a tool that sponsors and developers can adapt to advance their specific clinical trial and real-world evidence needs, while also remaining compliant with the FDA’s regulations and guidance for data authenticity, integrity and confidentiality.

 

For example, patients may be able to securely enroll in and contribute data to traditional clinical trials, pragmatic trials, observational studies and registries. Sponsors may be able to customize their apps to administer questionnaires assessing patient-reported outcomes, symptom scales or patient reports of prescription and over-the-counter medication use.