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Clinical Trial Blue Button: Returning Electronic Clinical Data to Clinical Trial Participants

Craig Lipset (Pfizer)
Data Liquidity Salon F
Slides:   1-PPT 

Clinical trials rely extensively on the participation of patients to share data. As these studies conclude, results are posted online and published in scientific journals. Little, however, is routinely given back to the patient to acknowledge their contribution.

This session will discuss:

  • Sharing study results with patients in lay language
  • Sharing individual electronic clinical data back with the research participant using the Blue Button

The benefits of this innovative new approach include:

  • Further empowering the patient with access to additional clinical data which they may use to improve their overall health and wellness (i.e. share with providers, integrate with other clinical data, etc)
  • Improve patient engagement in clinical trials with the potential to impact clinical trial recruitment and retention — a leading source of cost and delay in the conduct of trials
  • Enable a new research ecosystem of data sharing with patients

Published data demonstrates that over 90% of patients with access to a personally controlled health record are willing to share that data for research. (J Med Internet Res 2010;12(2):e14)
This presentation demonstrates the ability of research sponsors to engage patients in this new ecosystem by first sharing their data with patients, setting a new standard for trust and collaboration.

Photo of Craig Lipset

Craig Lipset


Craig Lipset is Head of Clinical Innovation within Worldwide Research & Development at Pfizer. Craig’s team is impacting clinical research through digital tools, innovative research approaches and unprecedented collaborations. Craig previously served as Venture Partner in Pfizer Venture Investments (Pfizer’s VC arm), where he focused on diversifying the company’s $50M annual budget for private investments in the areas of diagnostics and health technology. Craig was also Senior Director in Molecular Medicine, where he spearheaded initiatives driving innovation in clinical research and personalized medicine by drawing upon tools from health information technology, telemedicine, and eHealth.

Craig brings over 15 years of leadership and innovation in the field of drug development. He previously served as Associate Vice President of Program Management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International). Listed among the 2010 PharmaVOICE most inspiring people in the life sciences and among Pharmaceutical Executive’s 2011 Emerging Leaders, Craig recently served as program chair for the 2012 Annual Meeting of the Drug Information Association. His work was recently acknowledged with the 2012 BioIT Best Practices award for Clinical & Health IT. Outside of Pfizer, Craig serves on the Board of Directors for the Foundation for Sarcoidosis Research and as a Mentor at health tech accelerator Blueprint Health.

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