Background
The MyStudies Mobile Application (app) Platform is a generalizable mobile app that works on both Android and Apple phones. It can be used to collect consent and data from patients in real-time and link it to existing electronic health data. The system allows for the creation, distribution, and modification of questionnaires, as well as the ability for specified administrators to download patient responses from a HIPAA and FISMA compliant storage environment.
The system extends the capabilities of the mobile frameworks from Apple’s ResearchKit and Android’s ResearchStack through an intuitive front-end application and secure storage environment that can support health research studies. The platform supports single or multisite studies and can be implemented within highly secure data environments.
Projects and Branded Apps
IBD PROdigy & CARRA Registry App
Following the development of the FDA MyStudies app, several enhancements to the FDA-Catalyst MyStudies mobile app platform were planned to improve usability and facilitate the collection of detailed information and enable implementation of the app to facilitate collection of patient-reported data:
- IBD PROdigy app was launched to support the Study of a Prospective Adult Research Cohort Irritable Bowel Disease (SPARC IBD)
- CARRA Registry App was launched to support the PCORI Limit Juvenile Idiopathic Arthritis trial (LimitJIA)
COVID MyStudies
The COVID MyStudies application allows for secure and remote electronic consent. The end product is a signed consent form accessible by the patient or legally authorized representative and a copy which the investigator can access in a secure and compliant manner through the platform. The investigator can print the form or transfer an electronic copy into another electronic system.
Open Source System
All source code for the FDA MyStudies System is publicly available on GitHub and researchers are encouraged to set up their own instance of the system for their own purposes. Through September 2020, FDA is providing support to engage with the developer community and provide regular updates with new features and fixes to issues reported by our partners, researchers, and developers.
Related Links
- FDA MyStudies Technical Background
- Collection of Patient-Provided Information Through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research
- FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries
- COVID MyStudies
- GitHub
- Publications and Presentations
- The FDA MyStudies app: a reusable platform for distributed clinical trials and real-world evidence studies
- CDER SBIA Webinar: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies
- A Generalizable Smartphone-Based Clinical Research Platform