An open-source mobile technology created by the Food and Drug Administration (FDA) will improve the process of collecting patient-reported outcomes for research and, in turn, will help the agency promote patient-focused product development. 

In recent years, the FDA has made it a priority to consider patient views and experiences when examining complex issues involving the regulation of medical devices and their use by patients. However, before November 2018, no publicly available mobile platform existed to recruit patients, get their consent and collect patient-reported data for clinical research while meeting FDA regulatory requirements with respect to data integrity and federal standards regarding patient privacy. 

The FDA MyStudies platform is the mobile technology accompaniment to the agency’s other efforts aimed at incorporating patient voices and experiences into product development and regulation. It was developed by the FDA and private sector partners, but open-source code and technical documentation (for Apple or Android frameworks) are being released to the public, so the app and patient data storage system can be reconfigured by organizations conducting clinical research.  

Since the FDA MyStudies app’s release to the public in 2018 via the software repository GitHub, 25 groups across the nation have cloned it for their purposes. Currently, the app is being rebranded for two research projects: one in collaboration with the Patient-Centered Outcomes Research Institute (PCORI), and the other in collaboration with the Crohn’s & Colitis Foundation. 

Funding for the FDA MyStudies app was initiated by a $2 million grant from the US Department of Health and Human Services’ Patient-Centered Outcomes Research Trust Fund.

The FDA MyStudies app is designed to help collect real-world data directly from patients and enable data linkage to a variety of sources, such as clinical trial data capture systems, electronic health records, insurance claims, product and disease registries, and potentially patients’ other digital health technology such as wearables. While serving as a patient source of data, these valuable data streams can inform clinical trial development and real-world evidence studies as well as potentially lead to new medical product development and inform regulatory decision-making.  

Funding for the FDA MyStudies app was initiated by a $2 million grant from the US Department of Health and Human Services’ Patient-Centered Outcomes Research Trust Fund. Boston-based Harvard Pilgrim Health Care Institute was chosen to build the app, with Boston Technology Corp. of Marlborough, Massachusetts, as the mobile app developer and Seattle-based LabKey Corp. as the infrastructure provider. The FDA partnered with the Kaiser Permanente Washington Health Research Institute in Seattle to test the app’s functionality and engagement in a 2017 pilot study that explored medication use and health care outcomes of pregnant women. 

The FDA MyStudies app has the potential to support real-world evidence studies by capturing patient-reported outcomes, while expanding the range of endpoints available for study and improving the comfort and convenience for clinical trial participants.