The FDA MyStudies App: A Reusable Platform for Distributed Clinical Trials and Real-World Evidence Studies

Basic Details
Date
Friday, December 11, 2020
Type
Publication
Description

We developed a mobile application and secure patient data storage platform, FDA MyStudies, to address privacy, engagement, and extensibility challenges in mobile clinical research. The system extends the capabilities of the mobile frameworks Apple ResearchKit and ResearchStack through an intuitive front-end application and secure storage environment that can support health research studies. The platform supports single or multisite studies via role-based access and can be implemented within highly secure data environments. As a proof-of-concept, pregnant women participated in a descriptive study via the app in which data not routinely captured in electronic health records (EHR) were collected and linked with existing patient data to provide a more wholistic view of the patient and illustrate how patient data combined with EHR data could be used to support public health research.

Presenter(s)

Zachary Wyner, Sascha Dublin, Christina Chambers, Shyam Deval, Chayim Herzig-Marx, Shanthala Rao, Adam Rauch, Juliane Reynolds, Jeffrey S. Brown, David Martin

Corresponding Author

Jeffrey S. Brown; Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA
Email: jeff_brown@harvardpilgrim.org