Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.,Cambridge, MA 02138, USA The MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School are proud to co-host A Conference on Post-Trial Responsibilities: Ethics and Implementation. Introduction / Background: The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended. For the purposes of this conference, we will focus discussions on the following:
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:
This conference will bring together diverse stakeholders to address some of these questions. Objectives:
Session I: Setting the Stage (Moderator: I. Glenn Cohen) Objective: To introduce current ethical and regulatory approaches, as well as key controversies. Session II: Important Perspectives (Moderator: Barbara Bierer) Objective: To convey the range of stakeholder perspectives and current approaches from sponsors, regulators, patients, and investigators, and identify areas of convergence and divergence Session III: Lessons Learned: Case Studies on Implementing Post-Trial Responsibilities (Moderator: Holly Fernandez Lynch, Petrie-Flom Center) Objective: To better understand real world experiences implementing post-trial responsibilities, including both successes and failures, and to more clearly articulate and assess the complexities involved. Session IV: Working Toward Solutions: Group Discussion of Hypothetical Post-Trial Scenarios (Moderator: Mark Barnes)
For more information on the agenda, please click here. For more information on the scenarios, please click here. |