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From the Protocol to the Patient: Clinical Trial Data Disclosure

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
338

Room Number:
6D

Level:
Intermediate

Type:
Session

Title:
From the Protocol to the Patient: Clinical Trial Data Disclosure

Chair(s):
Barbara Godlew, RN
President
The FAIRE Company, LLC, United States

Description:
This session focuses on US and EU clinical trial disclosure requirements, including results reporting and patient-level data disclosure. This session applies to regulatory, clinical operations, medical writing, patient advocacy, and other areas.

Learning Objective(s):
Discuss current/future requirements of US and EU clinical trial disclosure regulations; Identify issues surrounding patient-level data disclosure; Describe patients’ experiences in receiving trial results, concerns over publicly releasing patient-level data, and thoughts on making clinical trial results understandable to patients and their families.

Presentation(s) & Speaker(s):
US Update of Clinical Trial Disclosure
Rebecca J. Williams, PharmD, MPH
Assistant Director, ClinicalTrials.gov
National Library of Medicine, NIH, United States

Clinical Trial Data Open for All?: An Update on the Current International Debate on Data Sharing
Hans-Georg Eichler, MD, MSc
Senior Medical Officer
European Medicines Agency, European Union, United Kingdom

Preparing Disclosures for Patient Populations
Stephen Mikita, JD
Patient Advocate
Spinal Muscular Atrophy Foundation, United States