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Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
Clinical study data is increasingly becoming available in the public domain. This session presents how the data is being utilized by patients and how sponsors are modifying their internal procedures to prepare disclosure-ready documents. Join the Clinical Trial Disclosure Community for a follow up Round Table discussion on Wednesday, June 26, 1:00-2:00PM in the DIA Community Zone 2, Sails Pavilion.
Learning Objective : Discuss how publicly available clinical data is being utilized by patient organizations; Describe approaches industry is taking to write clinical documents and provide clinical data for disclosure; Discuss Health Canada’s new regulation on publication of clinical trial information.
Speaker(s)
Overview of Health Canada’s Public Release of Clinical Information Initiative
Andre Molgat, PHD
Health Canada, Canada
Head of Operations, Public Release of Clinical Information
Clinical Trial Disclosure and Transparency: An Industry Perspective
Elizabeth Roberts, MSC
UCB Inc., United States
Data Policy and Privacy Lead
How Clinical Data is Being Used by Patients and Patient Organizations
Deborah Collyar
Patient Advocates In Research (PAIR), United States
President