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Enabling Participants' Access to the Electronic Clinical Trial Data: The Blue Button Project
Session Chair(s)
David P. Leventhal, MBA
Enterprise Clinical Trial Data Sharing Lead, Global Data Dissemination
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 : 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.
Speaker(s)
Deploying the Blue Button to Advance Clinical Research: The Blue Button Project
Munther Baara, MS
EDETEK, Inc. , United States
Vice President, Product Strategy and Innovation
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, RPh
Antidote, United States
Chief Development Officer
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