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Balancing Clinical Trial Disclosure and Transparency with Global Data Protection Regulations
Session Chair(s)
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
Global clinical trial disclosure requirements and initiatives result in extensive amounts of clinical data in the public domain. This session will discuss how the increasing transparency demands and competing privacy obligations are being addressed.
Learning Objective : Discuss the competing challenges of increasing demand to make more clinical data publicly available and data privacy obligations; Describe approaches industry is taking in preparing clinical documents for public disclosure to minimize risks of patient re-identification; Recognize patients’ concerns on disclosure risks.
Speaker(s)
Legal Challenges in Balancing Data Transparency and Data Privacy Obligations
Attorney, Ropes & Gray LLP, United States
How Health Literacy Strategies Help Create Usable Clinical Trial Information for Patients
President and Chief Executive Officer, Health Literacy Media, United States
Preparing Global Clinical Documents for Disclosure
Medical Writing Therapeutic Area Lead, Pfizer, United States
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