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.
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.
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.
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.
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