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Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Session 7: Sharing Patient Level Data: Where Are We Headed?

Session Chair(s)

Marla Jo  Brickman, PhD

Marla Jo Brickman, PhD

  • Senior Director - Clinical Data Transparency/Compassionate Access Lead
  • Pfizer Inc, United States
The sharing of patient-level data has now become the new norm. Provisions for sponsors of clinical research (industry, academia, government) are being added to regulations and guidelines requiring these sponsors to make the de-identified/anonymized data supporting this clinical research available to other researchers. In this session, we will discuss the practical implications of current data sharing models, as well as, explore future models and what this means for the research community, government, industry, and academia.
Learning Objective :
  • Explain current models for the sharing of patient-level data
  • Recognize proposals for future models for the sharing of patient-level data
  • Interpret first-hand accounts in sharing/using patient-level data
  • Speaker(s)

    Sean  Khozin, MD, MPH

    Speaker

    Sean Khozin, MD, MPH

    • Associate Director (Acting), Oncology Center of Excellence
    • FDA, United States
    Rebecca  Li, PhD

    Speaker

    Rebecca Li, PhD

    • Senior Advisor, MRCT Center; Executive Director
    • Vivli Center for Global Clinical Research Data, United States
      Panel Discussion

    Q&A Panel Discussion

    Panel Discussion

    • All Session Speakers, United States

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    Disclosures 101


    Short Course 2

    Preparing Documents for Disclosure and Public Sharing 


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