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Westin Arlington

Sep 23, 2024 7:30 AM - Sep 24, 2024 3:30 PM

801 North Glebe Road, Arlington, VA 22203

Global Clinical Trial Disclosure and Data Transparency Conference

Untangle the complexities of global disclosure practices, learn about recent regulatory modernization, and discuss cross-regional strategic considerations.

Session 1: Increase Value of Publicly Disclosed Clinical Trial Information

Session Chair(s)

Kelly  Coulbourne, MS

Kelly Coulbourne, MS

Director, Clinical Trial Transparency and Disclosure

Pfizer Inc, United States

The focus of this session is to discuss how companies and regulators can increase the value of trial information being communicated to clinical trial participants and the public. There are ongoing efforts to enhance the end user experience with public registries and sponsor organizations have started piloting returning individual data to trial participants.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Measure the value of registration and results information to clinical trial participants and the public
  • Apply existing solutions to implement processes for returning individual participant level data
  • Discuss the impact on the modernization efforts to the public’s experience with ClinicalTrials.gov information

Speaker(s)

Zack  Fey

How Can Value Be Added to Registration and Results Postings?

Zack Fey

CISCRP, United States

Manager, Medical Writing

Jean  Sposaro, MHS, LLM

Enabling Individual Participant Data Return (iPDR)

Jean Sposaro, MHS, LLM

Bristol-Myers Squibb Company, United States

Director, Global Drug Development Operations, Industry Collaborations

Stacey  Arnold, PhD

Update on ClinicalTrials.gov Modernization Effort

Stacey Arnold, PhD

National Institutes of Health (NIH), United States

Results Team Subject Matter Expert

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