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. BTC’s role within the project was to create participant mobile app(s) for data collection, along with a web-based configuration portal for managing study content while LabKey provided a secure back-end storage environment for storing and accessing real-world data. The biggest impetus for the FDA when creating the platform was delivering on the ACA (Affordable Care Act) mandate to “build data capacity for comparative clinical effectiveness research.” As a result, 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.
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.
1) A participant-friendly user interface
2) Use of standard frameworks for both ResearchKit (iOS) & ResearchStack (Android)
3) Gateway capability to publish multiple studies using a single mobile app
4) Web-based configuration portal for managing study content
5) Secure storage environment
6) Can be set up as HIPAA & FISMA compliant
7) Partitioned for distributed research
8) Responses are available in broadly compatible formats (e.g., SAS, Excel)
9) Reusable infrastructure
10) Enrollment and consent features as standard platform functionality
11) Automatic capture of contextual real-world metadata
12) Aid in the recruitment, engagement, and retention of data
1) Building mobile app(s) on iOS and Android using the open-source ResearchKit and ResearchStack frameworks
2) Building the web configuration portal for management of study content
3) Constructing a user registration server on LabKey’s framework
3) Managing integrations between different platform components
5) Implementing UX/UI design for the web configuration platform (WCP) and mobile app(s)
6) Supporting focus group testing for the app(s) and web configuration portal
7) Leading in requirements gathering, architecture, and design of the overall platform
8) Supporting user testing for the platform
9) 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.
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.
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 the 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.
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