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From the Protocol to the Patient: Clinical Trial Data Disclosure
Session Chair(s)
Barbara Godlew, RN
Associate Consultant, Scientific Communications, GSC-Bio-Medicines
Eli Lilly and Company, United States
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 : 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.
Speaker(s)
US Update of Clinical Trial Disclosure
Rebecca Williams, PharmD, MPH
Essex, Part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert
Clinical Trial Data Open for All?: An Update on the Current International Debate on Data Sharing
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Preparing Disclosures for Patient Populations
Stephen Mikita, JD
Clinical Trials Transformation Initiative (CTTI), United States
Lead Project Manager
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