FDA MyStudies: Streamline clinical trials and data collection with real time, patient-reported outcomes



Web & Mobile

In 2017, The U.S. Food and Drug Administration (FDA) selected Harvard Pilgrim Health Care Institute to lead the development of the FDA MyStudies platform to facilitate the collection of real-world data from patients for research purposes. To help create the platform, Harvard Pilgrim selected Boston Technology Corporation and LabKey to be their development partners. Through their combined efforts, the FDA established the open-source MyStudies platform to provide a reference architecture to encourage the use of real-world data collection within clinical trials along with utilizing data submissions to find real-world evidence.

How come

What does
the platform

    The main goal of the FDA MyStudies platform is to collect patient, observer, and clinician reported real-world data for traditional clinical trials, patient registries, and observational studies. To collect this data users can actively and passively (via active tasks) provide information through a mobile app, which is available on iPhone and Android devices. Important information such as study resources, study progress, notifications, and reminders related to survey participation can also be shared through the app directly to participants phones. Lastly, to ensure the safety and protection of users’ data the platform can be deployed as HIPAA and FISMA compliant.

    How come

    What key features
    does the platform

      • A participant-friendly user interface
      • Use of standard frameworks for both ResearchKit (iOS) & ResearchStack (Android)
      • Gateway capability to publish multiple studies using a single mobile app
      • Web-based configuration portal for managing study content
        Secure storage environment
      • Can be set up as HIPAA & FISMA compliant
      • Partitioned for distributed research
        Responses are available in broadly compatible formats (e.g., SAS, Excel)
      • Reusable infrastructure
      • Enrollment and consent features as standard platform functionality
        Automatic capture of contextual real-world metadata
      • Aid in the recruitment, engagement, and retention of data
      How come

      How we
      helped & delivered

        • Building mobile app(s) on iOS and Android using the open source ResearchKit and ResearchStack frameworks
        • Building the web configuration portal for management of study content
        • Constructing a user registration server on LabKey’s framework
          Managing integrations between different platform components
          Implementing UX/UI design for the web configuration platform (WCP) and mobile app(s)
        • Supporting focus group testing for the app(s) and web configuration portal
        • Leading in requirements gathering, architecture and design of the overall platform
        • Supporting user testing for the platform
          Supporting the first patient trial run by Kaiser

        BTC’s guiding principles in platform design was to make the WCP and mobile app(s) flexible, customizable, extensible, and scalable. We also incorporated a way for researchers and developers to choose different components to customize platform deployment allowing them to run a suite of studies through one gateway app or a standalone app.

        How come


          Currently the FDA MyStudies platform is being utilized for two studies:

          The Limited Juvenile Idiopathic Arthritis (LIMIT-JIA) case study focuses on patients with limited juvenile idiopathic arthritis (children with 4 or less joints affected at diagnosis). This study, which is supported through the MyStudies platform, tests whether a 6-month course of a biologic medication used in the treatment of JIA can prevent the disease outcomes of extension to more joints, eye inflammation and/or the need for additional treatment as compared to usual care. In addition, this study also looks at the family perspective of enrolling in a research study after their child is diagnosed and what barriers this might present.

          The Crohn’s & Colitis Foundation (CCF) is utilizing the FDA MyStudies platform to conduct a study on how to expand IBD Plexus®- a research information exchange platform and registry that centralizes data and biosamples from diverse research cohorts – to incorporate the use of a mobile application designed to fill in important real-world data gaps and capture patient experience data beyond the clinical care system. The foundation is also using the platform to host IBD PROdigy, a digital IBD tracker tool that facilitates collection of patient-reported data at critical points throughout a patient’s disease course. Through IBD Plexus, the Foundation can link patient-reported outcome data collected through IBD PROdigy to clinical data, biosamples, and their derived molecular (genetic and ‘omics) data.

          Click here to learn more about BTC, our services, and how you can partner with us to work on your organization’s latest projects and how we can help you leverage the FDA MyStudies platform for your research needs.

          How come

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