The Evolving Clinical Trial Disclosure Global Landscape

Track:
Communities Showcase

Day & Time:
June 25, 4:00PM - 5:30PM

Session Number:
287

Room Number:
205B

Level:
Intermediate

Type:
Session

Title:
The Evolving Clinical Trial Disclosure Global Landscape

Chair(s):
Sarah Doyle Larson
Associate Director, Clinical Operations
Biogen Idec, United States

Description:
This session will present the current disclosure landscape, identify important global developments, discuss the potential impact that increased disclosure will have on clinical research, and identify how best to prepare for the future.

This session has been developed by the Clinical Trial Disclosure Community.

Learning Objective(s):
Recognize the recent events that are shaping the disclosure landscape; Evaluate how one company’s announcement to provide open access to data tables may influence clinical research; Assess how trial sponsors are preparing for disclosure of patient-level data, lay summaries and unredacted CSRs.

Presentation(s) & Speaker(s):
Panelist
Rebecca H. Li, PhD
Executive Director
Multi-Regional Clinical Trial (MRCT) Center at Harvard , United States

Panelist
Jacqueline Cole, MS
Oncology Clinical Operations Portfolio Management, NA Clinical Operations
Eli Lilly and Company, United States