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Collection of Patient-Provided Information Through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research

Basic Details
Date Posted
Status
Complete
Description

The purpose of this pilot project was to develop a generalizable mobile device application that can be used to collect data from patients in real-time and link it to existing electronic health data. This system will allow for creation, distribution, and modification of questionnaires on Android and iOS mobile phones, as well as the ability for specified administrators to download patient responses from a HIPAA and FISMA compliant storage environment. As an initial proof of concept, the project will not analyze a specific safety or comparative effectiveness issue.  However, descriptive linked data as well as data related to usability and patient engagement will be presented.  

Deliverable(s) (2)
The FDA MyStudies App: A Patient Centered Outcomes Research Trust Fund Enabler For Distributed Clinical Trials And Real World Evidence Studies The FDA MyStudies App: Appendices
Information
Time Period
September 2017 - December 2017
Population / Cohort
Pregnant women
Data Source(s)
Kaiser Permanente Washington Health Research Institute Members and the Kaiser Permanente Washington Sentinel Distributed Database
Related Link(s)
FDA’s MyStudies Application (FDA Webpage)
Open Source Code and Technical Documentation for the FDA MyStudies App
FDA In Brief: FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision-making
2017 ICPE Presentation: Developing a Mobile App for Studies of Medication Safety
FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries
AMIA Poster: Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance
AMIA Symposium: A Generalizable Smartphone-Based Clinical Research Platform
A Generalizable Smartphone-Based Clinical Research Platform
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research
The FDA MyStudies App: A Reusable Platform for Distributed Clinical Trials and Real-World Evidence Studies
Workgroup Leader(s)

Zachary Wyner, MPH; Chayim Herzig-Marx, PhD; Juliane Reynolds, MPH; Jeffrey Brown, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

David Martin, MD, MPH; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Member(s)

Alison Kawai, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA;

Sascha Dublin, MD, PhD; Predrag Klasnja, PhD; Linda Kiel; Catherine Lim; Karen Byeman, Kacie Washington; Group Health Research Institute, Seattle, WA

Christina Chambers, MD; University of California San Diego, Family Medicine and Public Health Department, San Diego, CA

Adam Rauch, Bernard Lee, Brian Connolly, Susan Hert, Angelica Omaiye; LabKey Software, Seattle, WA

McKinley Hackett, Shyam Deval, Shanthala Rao, Will Crosby; Boston Technology Corporation, Marlborough, MA