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  5. An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – May 9, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

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

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Speakers and Recordings

Webinar Recording Speaker 
Introduction to FDA MyStudies Mobile App System  David Martin, MD, MPH
Associate Director for Real World Evidence Analytics Office of Medical Policy
Center for Drug Evaluation and Research (CDER) FDA  

A Demonstration of the FDA MyStudies Mobile App System:
Patient and Researcher Experiences Recording I
Patient and Researcher Experiences Recording II

  • Mobile application
  • Web Configuration Portal (WCP) 
  • Response and Registration Servers
Zachary Wyner, MPH
Senior Health Informatics Analyst Department of Population Medicine
Harvard Medical School & Harvard Pilgrim Health Care Institute
Questions and Answers MyStudies Team
Mobile Application and WCP: Usability and Technical Overview

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

Ranjani Rao, MS
Chief Technology Officer
Boston Technology Corporation

Response Server Technical Overview Adam Rauch
Vice President of Product Strategy
LabKey Software
Deploying the MyStudies System in a Compliant Manner Stuart MacDonald
Director of Systems Engineering
LabKey Software
Questions and Answers MyStudies Team
 

ABOUT THIS EVENT

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 will demonstrate the capabilities of the system as well as its associated web-based configuration portal and data storage environment. Developers will receive an orientation to the GitHub repository and will learn 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

Why attend?

  • Hear directly from FDA subject matter experts on the use of digital tools such as the FDA MyStudies platform to gather real-world data for research and help inform regulatory decision-making.
  • Understand the capabilities of the mobile apps built on iOS ResearchKit and Android ResearchStack frameworks, respectively.
  • Learn how the code base of these apps is designed to make them ‘framework apps’ and can be replicated for any number of studies, with minimal coding effort, to set up new apps for new studies.
  • Observe in real-time how study content can be created, published, and managed using the web-based Configuration Portal. See how those changes are reflected dynamically in the mobile apps and the Response Server.
  • Take a deep dive into the capabilities and architecture of the Response Server to understand how responses are processed and stored. Learn about the many options provided for retrieving and analyzing these data, including linking responses to patient records.
  • Identify features of the MyStudies platform intended to enhance usability and user experience.
  • Understand the conceptual architecture of the MyStudies platform including use of iOS ResearchKit and Android ResearchStack in order to facilitate future private and public sector development.
  • Take a guided virtual tour of the major components of the MyStudies GitHub repository and ask questions of subject matter experts from Boston Technology Corporation and LabKey who developed the platform applications.
  • Learn how the MyStudies server components can be deployed in a FISMA- and HIPAA-compliant cloud hosting environment. Review key deployment decisions made and best practices used in hosting multiple studies using this system.

RESOURCES