In 2017, the U.S. Food and Drug Administration (FDA) began the process of building a mobile application to collect real-world data directly from patients. This application would help data collection for clinical trials, observational studies, and registries. Through the FDA-Catalyst program, Harvard Pilgrim Health Care Institute (HPHCI) was selected to lead the development of the mobile application, known as FDA MyStudies.
The effort was funded by an award to FDA scientific staff from the Patient Centered Outcomes Research Trust Fund, administered by the Associate Secretary for Planning and Evaluation (ASPE) of the Department of Health and Human Services.
Harvard Pilgrim selected both the mobile application development firm Boston Technology Corporation (BTC) and LabKey as their development partners for FDA MyStudies. BTC would develop the user-friendly mobile interface. LabKey was tasked with building a secure back-end storage environment for collected data.
The bulk of the components used in the development of the secure data storage environment previously existed in Server SDMS. However, three key areas of custom development were required to support the project’s use:
Enrollment Tokens: The application needed to restrict participants’ enrollment to a specific study cohort, as well as match the collected study data to external systems (e.g., EHRs). This required unique tokens for each participant, assigned upon registration in the app.
Automatic Schema Creation: The team needed to eliminate the need for manual schema development. Study questionnaire creation needed automatic generation of a new database schema.
Mobile App Response Handling: The application required automated parsing of the JSON responses sent by the mobile application. This automation would enable scalable storage of results for study questionnaires.
The project’s long-term goal was to expand the use of real-world data across research programs.
To reach this goal, the application framework needed to support a broad range of potential healthcare topics. And, this need to be done with configuration rather than requiring development for each new project. Server SDMS’ flexible, science-specific architecture proved a great fit for this goal.
Additionally, Server SDMS already had the ability to handle PHI/PII data in a manner compliant with HIPAA and FISMA regulations.
Finally, the FDA required that FDA MyStudies be released as open source. LabKey Server SDMS’ Community Edition was already an open source platform licensed under Apache 2.0. It could support this distribution model without any changes to its existing licensing.
LabKey composed the back-end storage environment of three independent web applications:
Response Server: Stores data captured via the mobile application and provides secure access for data analysis.
Registration Server: Manages participant authentication, preferences, notifications, and consents.
Web Configuration Portal: Used to design study questionnaires and store configurations (including consent forms, eligibility tests, surveys, and study resources).
The dispersed data model ensures secure partitioning of all identifying information from response data, ensuring patient privacy. Server SDMS provides role-based governance of the data stored on the Registration and Response servers. This means that certain data are only accessible by authorized users.
When it is time for analysis, data from the response server is accessible by authorized users. There are a few options for access, including built-in analytics, download to SAS or R, or export to Excel and other standard formats.
Harvard Pilgrim contracted with Kaiser Permanente Washington Health Research Network (KPWHRN) to evaluate the viability of the application. They launched a pilot study, examining gestational medication use and healthcare outcomes of pregnant women.
For the pilot program, they used LabKey’s cloud hosting services to manage the storage of study data in a secure AWS cloud environment.
Participants who successfully completed the study reported high levels of usability. They also reported comfort sharing sensitive information using the app.
The pilot was deemed a success. In Fall 2018, the FDA released the open source code and documentation publicly for use in other studies.
Since its release, the FDA MyStudies platform has been cloned by at least 25 groups, specifically supporting a clinical trial and a disease registry. It was also used to collect informed consent for clinical trials during COVID-19 restrictions as COVID MyStudies.
The collaboration between Harvard Pilgrim Health Care Institute (HPHCI), BTC, and LabKey to develop the FDA MyStudies platform demonstrates the successful integration of technology and healthcare research. Server SDMS played a pivotal role in creating a flexible and secure back-end environment for collecting real-world data directly from patients.