FDA’s MyStudies Application (App) Technical Background
The FDA MyStudies app lets patients provide data that can be linked to traditional clinical trials, real-world trials, observational studies, and registries.
Open source code and technical documentation were placed in the public domain in November 2018. This technical roadmap allows researchers and developers to customize, rebrand, and use the FDA MyStudies app for their clinical trials and studies. Part of this customization includes a guide to rebranding the app. Researchers and developers who would like to customize FDA MyStudies can rebrand it.
The FDA MyStudies App has several defining features:
- The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight.
- The app is configurable for different therapeutic areas and health outcomes, which reduces software development hurdles for non-FDA users.
- The data storage environment is partitioned to support multiple clinical trials from different organizations, multi-site trials, or “distributed database” studies.
- The code for MyStudies is open source so software developers can improve upon its capabilities.
Open source code has been released for two versions of the app. One is built on Apple’s ResearchKit (iOS) framework. The other is built on the open source ResearchStack framework, which runs on Google’s Android.
Development and testing of FDA MyStudies were funded by the Patient Centered Research Outcomes Trust Fund through an award to the Associate Director for Real World Evidence Analytics, FDA Office of Medical Policy, David Martin, MD, MPH. Because FDA MyStudies allows direct contact with patients, FDA projects involving the app are classified as clinical research under the FDA-Catalyst program.
FDA-Catalyst is managed by the Harvard Pilgrim Health Care Institute, the prime contractor for the Sentinel Contract. It is led by the FDA Office of Medical Policy. LabKey developed the secure patient data storage environment and Boston Technology Corporation developed the mobile app based on Apple ResearchKit (iOS) and Google Android ResearchStack frameworks.
The agency is currently supporting the use of the FDA MyStudies app in the Limit JIA clinical trial and SPARC IBD study as real-world evidence demonstration projects. The app has been rebranded as the CARRA Registry/Limit JIA app and the IBD PROdigy app. Because of the COVID-19 public health emergency, recruitment into the Limit JIA trial has been paused.
Software development funded by the Crohn’s & Colitis Foundation, which enables the SPARC IBD study to push information to IBD PROdigy and trigger questionnaires connected to non-routine medical procedures, is in the final testing phase and IBD PROdigy will launch in the summer of 2020.
MyStudies App Technical Documents
- Open Source Code and Technical Documentation for the FDA MyStudies App on GitHub
- MyStudies Mobile App Quick Overview for Research
- The FDA MyStudies App: A Patient Centered Outcomes Research Trust Fund Enabler for Distributed Clinical Trials And Real World Evidence Studies
Additional open source code built on the Apple ResearchKit (iOS) framework and the ResearchStack framework for Google’s Android operating system has been released since November 2018, and additional updates will be released over the next several quarters. These enhancements continue to simplify configuration for researchers and improve the experience for participants. Additional details can be found in the Mobile App Quick Overview for Research document.