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The MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School are proud to co-host the Post-Trial Responsibilities Conference: Ethics and Implementation.
Background
Law, policy, and guidance in regard to post-trial access can be vague, conflicting, and lacking in concrete solutions. Questions relating to this notion include:
- What types of interventions should be included within post-trial access obligations?
- What is a reasonable duration for provision of post-trial access?
- 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 obligations?
Discussion of Solutions to Post-Trial Access
This conference will bring together diverse, global stakeholders to address and develop consensus around:
- articulating and understanding the range of perspectives relating to post-trial access
- implications of the 2013 Declaration of Helsinki revisions (and other guidance on post-trial access) for clinical research sponsors, investigators, and other stakeholders in the U.S. and abroad
- drawing lessons from successful and unsuccessful attempts to implement post-trial access policies
- potential scenarios and practical solutions for post-trial access to medicines that may inform policy in this important area moving forward
Session I: Setting the Stage (Moderator: Glenn Cohen): To introduce current ethical and regulatory approaches to “post-trial access,” as well as key controversies with speeches by global regulators.
Session II: Important Perspectives (Moderator: Barbara Bierer): To convey the range of stakeholder perspectives and current approaches to the post-trial access issue from sponsors, regulators, patients, and investigators, and identify areas of convergence and divergence with speakers from government, industry and non-profit
Session III: Potential Models and Case Studies of Post-Trial Access (Moderator: TBD): To better understand real world experiences with post-trial access, including both successes and failures, and to more clearly articulate and assess the complexities involved with speakers from government, industry and non-government organizations