返回 Agenda
Session 1: Increase Value of Publicly Disclosed Clinical Trial Information
Session Chair(s)
Kelly Coulbourne, MS
Director, Clinical Trial Transparency and Disclosure, Pfizer Inc, United States
The focus of this session is to discuss how companies and regulators can increase the value of trial information being communicated to clinical trial participants and the public. There are ongoing efforts to enhance the end user experience with public registries and sponsor organizations have started piloting returning individual data to trial participants.
Learning Objective : At the conclusion of this session, participants should be able to:- Measure the value of registration and results information to clinical trial participants and the public
- Apply existing solutions to implement processes for returning individual participant level data
- Discuss the impact on the modernization efforts to the public’s experience with ClinicalTrials.gov information
Speaker(s)
Zack Fey
Manager, Medical Writing, CISCRP, United States
How Can Value Be Added to Registration and Results Postings?
Jean Stimola-Sposaro, MHS, LLM, RAC
Vice President of Memberships and Partnerships, Digital Trials and Research Alliance (DTRA), United States
Enabling Individual Participant Data Return (iPDR)
Stacey Arnold, PhD
Results Team Subject Matter Expert, National Institutes of Health (NIH), United States
Update on ClinicalTrials.gov Modernization Effort