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CDER SBIA Webinar: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies

Event Information
Date
Time
Time
10:00am - 3:00pm EST
Event Type
Webinar
Description

The FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries.

This event demonstrated the capabilities of the system as well as its associated web-based configuration portal and data storage environment. Developers received an orientation to the GitHub repository and learned helpful tips for setting up and configuring the system for study managers and participants.

Intended Audience:​

  • Professionals involved in Clinical Research, Post Market Studies, Regulatory Affairs, Medical Affairs, Real World Evidence, Health Economics and Outcomes Research, and Population Health Management
  • Application developers and Secure Data Storage and Analytics Solutions developers working in the health care space
  • Foreign regulators

Date: May 9, 2019
Time: 10:00 AM - 3:00 PM EST
Location: Webinar

Event Materials

Webinar Recordings & Materials: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – May 9, 2019

The following sessions of the webinar were recorded. Please visit the link above for more details.

  • Session One: Introduction to FDA MyStudies Mobile App System
  • Session Two: A Demonstration of the FDA MyStudies Mobile App System: Patient and Researcher Experiences
  • Questions and Answers
  • Session Three: Mobile Application and WCP: Usability and Technical Overview
  • Session Four: Response Server Technical Overview
  • Session Five: Deploying the MyStudies System in a Compliant Manner
  • Questions and Answers and Closing Remarks
     
Information
Host

U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA)

Related Assessment(s)
FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries
Pilot Project: Collection of Patient-Provided Information through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research
FDA’s MyStudies Application (FDA Webpage)
Presenter(s)

David Martin, MD, MPH
Associate Director for Real World Evidence Analytics
Office of Medical Policy
Center for Drug Evaluation and Research (CDER)
FDA

Shyam Deval, MS, MBA
President & Chief Customer Officer
Boston Technology Corporation

Ranjani Rao, MS
Chief Technology Officer
Boston Technology Corporation

Adam Rauch
Vice President of Product Strategy
LabKey Software

Stuart MacDonald
Director of Systems Engineering
LabKey Software

Jeffrey Brown, PhD
Associate Professor
Department of Population Medicine
Harvard Medical School & Harvard Pilgrim Health Care Institute

Zachary Wyner, MPH
Senior Health Informatics Analyst
Department of Population Medicine
Harvard Medical School & Harvard Pilgrim Health Care Institute