Thursday, September 18, 2014
Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.
This event is free and open to the public, but due to limited seating registration is required. Please register online.
Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions. Areas that currently lack clarity include:
- What types of interventions or resources should be included within post-trial responsibilities?
- What is a reasonable duration for post-trial responsibilities to extend?
- What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?
This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.
- To discuss implications of international guidance on post-trial responsibilities for clinical research sponsors, investigators, and other stakeholders
- To articulate and understand the range of perspectives on post-trial responsibilities
- To draw lessons from successful and unsuccessful attempts to implement post-trial access policies
- To discuss potential scenarios and practical solutions for post trial responsibilities that may inform policy in this important area moving forward
- To identify key priorities for a Post-Trial Responsibilities Working Group to be launched by the Multi-Regional Clinical Trials Center at Harvard.
For a more detailed draft agenda, please visit the conference website.
Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.