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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:
- How are recommendations regarding post-trial responsibilities influenced by the trial phase and/or prior experience with the intervention?
- What types of interventions or resources should be included within post-trial responsibilities? Do recommendations include ancillary care, treatment of side effects and adverse events, etc.?
- What is a reasonable duration for post-trial responsibilities to extend?
- What is the mission and purpose of various stakeholders (sponsors, governments, investigators, etc.) in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities? In particular, how do government and sponsor responsibilities relate to each other? Do recommendations change when research is sponsored by non-profit entities?
This conference will bring together diverse stakeholders to address some of these questions.
- To discuss implications of international guidance on post-trial responsibilities for clinical research sponsors, governments, 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
The full agenda is now available on our website.
Please make sure to read the Hypothetical Post-Trial Scenarios prior to the event.
Cosponsored with the Multi-Regional Clinical Trials Center at Harvard University.