FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries

Project Title FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries
Date Posted
Tuesday, October 16, 2018
Status
In progress
Description

Analysis of health outcomes can be limited because data in electronic health record (EHR) and claims systems omit information like over-the-counter drug use, patient pain and discomfort, social behaviors, and environmental factors. A pilot project has addressed opportunities to enhance the information collected on patient experience to improve such analyses. The pilot project workgroup created a customizable mobile device application (app), FDA MyStudies, based on existing mobile research frameworks to collect patient data in real time and demonstrated that patient-reported information can be combined with data from the Sentinel Common Data Model for individual assessments as needed. The app utilizes a web-based tool for creation and distribution of questionnaires and supplementary materials. Patient responses are stored in a privacy-protecting cloud-based repository.

This project will include implementing several enhancements to the FDA-Catalyst MyStudies app to improve its usability and facilitate collection of detailed information. The work includes implementation of the app to facilitate collection of patient-reported data for up to two Patient-Centered Outcomes Research Institute (PCORI) pragmatic trials and one PCORI registry selected by the FDA.

View the pilot project here

Workgroup Leader(s)

Jeffrey Brown PhD; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

David Martin MD, MPH; Center for Drug Evaluation and Research, Office of the Center Director, FDA, Silver Spring, MD

Workgroup Members

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

Data Sources
Pragmatic clinical trial and patient registry data, patient reported outcomes
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