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Post-Trial Access: Ensuring Patient Access Across the Development Spectrum
Session Chair(s)
Karla Childers, MS
Vice President, Bioethics, Policy & Partnerships
Johnson & Johnson, United States
Clinical trials are an important way many patients gain access to life saving treatment they might not otherwise be able to obtain. Once the trial ends for an individual patient, what happens during the time treatment stops and the investigational agent becomes approved? Sponsors of clinical trials for life threatening diseases need to plan proactively for the management of this transition and engage with downstream stakeholders to ensure continued access to beneficial treatments.
Learning Objective : Define what is meant by post-trial access; Discuss the bioethical principles behind providing post-trial access; Describe the planning that should be undertaken in advance of initiating a trial for a life threatening disease.
Speaker(s)
Development of a Common Ethical Framework for Post Trial Responsibilities
Rebecca Li, PHD
Vivli , United States
Executive Director, Center for Global Clinical Research Data
Post-Trial Access: Terminology and Ethical Concepts Matter
Luann Van Campen, PHD, MA, MS
United States
Founder & President
Panelist
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV