|Project Title||FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries|
Tuesday, October 16, 2018
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.
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
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
Pragmatic clinical trial and patient registry data, patient reported outcomes
- Vaccines, Blood & Biologics
- Devices and Radiologic Health