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Enabling Participants' Access to the Electronic Clinical Trial Data: The Blue Button Project

Processes and Technologies for Clinical Research

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:

Room Number:



Enabling Participants' Access to the Electronic Clinical Trial Data: The Blue Button Project

David Leventhal
Director, Clinical Innovation, Worldwide Research and Development
Pfizer Inc, United States

Historically, patients participating in clinical trials do not have an easy way to receive or use the clinical data generated during a trial to improve their personal health and wellness. This session will discuss how a large pharmaceutical company, in December 2013, launched the Blue Button Project, an innovative project enabling patients who have participated in specified clinical trials the opportunity to download their individual clinical data. Using the Blue Button standard launched by the White House, patients are empowered to use their individual electronic clinical data to improve their overall health and wellness, from sharing data with health care providers to powering clinical risk assessment tools.

Learning Objective(s):
Describe the context for the Blue Button and its role in empowering patients through access to their health data; Identify the rationale for the project and the diverse stakeholders involved in the implementation; Discuss key challenges and solutions for implementation to help enable other research sponsors to share data with their trial participants; Discuss the expected evolution and the pathway for two-way data sharing with research participants to transform the conduct of clinical trials.

Presentation(s) & Speaker(s):
Deploying the Blue Button to Advance Clinical Research: The Blue Button Project
Munther Baara, MS
Senior Director, Clinical Paradigm
Pfizer Inc, United States

Impact of Access to Data for Study Participants: The Patient Perspective
Regina Holliday
Patient Activist and Mural Artist, United States

Introduction to the Blue Button: Empowering Patients With Health Data
Thomas A. Krohn
Advisor, Clinical Open Innovation
Eli Lilly and Company, United States