Status: Completed Project
The FDA has developed a robust national electronic surveillance system, Sentinel, for monitoring FDA regulated medical products and devices. Sentinel, is a distributed research network, using existing electronic health care data from multiple sources to support FDA surveillance activities. In a distributed network, data is held locally at the data partner site, and queried to request information on a specific research question. Currently, Sentinel is comprised largely of administrative and claims data from health insurers (i.e., data partners) and there is no way to incorporate information collected directly from patients.
PROJECT PURPOSE & GOALS
This project created the infrastructure for collecting data from patients through a mobile device application, allowing patient generated health data (PGHD) to be linked with a single data partner that participates in the Sentinel distributed network. The project developed and piloted a mobile application to capture data from pregnant women. As a result, researchers were able to query Sentinel for both the new PGHD and the data routinely captured by the Sentinel data partner. This effort serves as a model for future applications. The mobile application could be re configured to collect information from another patient population or a disease, so that other researchers or U.S Department of Health and Human Services (HHS) agencies could answer other research questions of interest. The project is now known as the “FDA MyStudies App”.
Identify and recruit pregnant women to participate in the data partner pilot
Develop a mobile device application
Link data provided by recruited pregnant women through the mobile application with existing data from the pilot data partner collaborator
PROJECT ACHIEVEMENTS & HIGHLIGHTS
The FDA has developed data transmission and storage procedures, as well as a secure patient data storage environment.
An integrated health care delivery system, Kaiser Permanente Washington Health Research Institute, was selected to pilot test the mobile application among pregnant women and to conduct analyses of the resulting data. The pilot cohort enrollment goal was reached, and the project’s questionnaires and research protocol received IRB approval.
Data collection completed December 2017. The team performed a descriptive analysis of exposures and health outcomes of the pilot cohort using crosswalk-matched data from both the mobile application and existing electronic health data formatted in the Sentinel Common Data Model or available within the Kaiser Permanente electronic health record (EHR) system.
The FDA launched its mobile application on the Google Play store and the Apple Store. Prior to the launch, a prototype application had been built for testing and feedback.
The team produced two reports for this project. One is a report on procedures used to obtain participant contact information and the other describes patient feedback on the mobile application.
PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES
The project team published a final report in October 2018, available here: https://aspe.hhs.gov/system/files/pdf/259016/FDAMyStudiesAppAPatientCenteredOutcomes.pdf. The report appendix is available here: https://aspe.hhs.gov/system/files/pdf/259016/AppendicesCollectionPatientProvidedInfo.pdf
The source code and accompanying technical documents are available on GitHub: https://github.com/PopMedNet-Team/FDA-My-Studies-Mobile-Application-System
The FDA MyStudies App is publically available here: https://www.fda.gov/drugs/science-and-research-drugs/covid-mystudies-application-app
Presented “Developing a Mobile App for Studies of Medication Safety” at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management (August 2017): https://www.sentinelinitiative.org/sites/default/files/communications/publications-presentations/Sentinel-ICPE-2017-Presentation-Mobile-App.pdf
Presented “Engaging Patients in Evidence Generation” at the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative (April 2017): https://nam.edu/wp-content/uploads/2017/04/Martin-NAS-042917.pdf
A poster presentation at the AMIA Joint Summits on Translational Science titled, “Collection of Patient Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance,” in March 2017.
The team presented “Developing a Mobile App for Studies of Medication Safety” at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management (August 2017). The presentation is available here: https://www.sentinelinitiative.org/sites/default/files/Sentinel-ICPE-2017-Presentation-Mobile-App.pdf
The team presented “Engaging Patients in Evidence Generation” at the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative (April 2017). The presentation is available here: https://nam.edu/wp-content/uploads/2017/04/Martin-NAS-042917.pdf
A project team member demonstrated the mobile app and web configuration portal at the American Medical Informatics Association in San Francisco, California in November 2018.
A project team member presented “Mobile Technologies – Opportunities and Regulatory Considerations” at the 34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Prague, Czech Republic in August 2018.
A project team member presented the FDA My Studies App within a larger presentation regarding real world data and evidence at the yearly European Commission/European Medicines Agency –US FDA Bilateral Meeting in June 2018. The title of the presentation was “Real World Data and Evidence: “Deep Dive” updates regarding Drug Development and Post-Marketing Monitoring”.
Project team members presented the project to the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) in February 2018. BBCIC was considering the utility of the app for biologics and biosimilars studies.
Below is a list of ASPE-funded PCORTF projects that are related to this project
Conceptualizing a Data Infrastructure for the Capture and Use of Patient-Generated Health Data – This project was initiated to identify challenges and opportunities that support the capture, use, and sharing of Patient-Generated Health Data (PGHD). This project developed a white paper that describes the current policy landscape, challenges and opportunities for the use of PGHD in research and care delivery through 2024. The white paper addresses seven topics areas including: patient recruitment for research studies and trials; collection and validation of data and tools; data donation; ability to combine PGHD with medical record data in multiple ways; data interoperability; big data analysis; regulatory overview. Additionally, the project conducted pilots that tested the concepts discussed in the white paper. The insights from the white paper can be used to inform future policies and guidance that promote standardized data collection of PGHD, increase its consistency and utility for research, clinical uses, and other analytic activities.