Ethics and Implementation

Conference Description

Who:

Clinical research sponsors, investigators, funders, regulators, trial participants, and other stakeholders

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 focused 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 brought together diverse stakeholders to address some of these questions.

Objectives:

Agenda:

7:30 – 8:00am Participants Arrive, Breakfast, and Registration

8:00 – 8:05am Welcome Remarks

8:05 – 8:15am The Potential Scope of the Post-Trial Access Issue

Session I: Setting the Stage (Moderator: I. Glenn Cohen)

Objective: To introduce current ethical and regulatory approaches, as well as key controversies.

10:00 – 10:15am Break

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

12:15 – 12:45pm Short break to pick up lunch, reseat for next session

Session III: Lessons Learned: Case Studies on Implementing Post-Trial Responsibilities (Moderator: Holly Fernandez Lynch)

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.

2:35 – 2:45pm Break

Session IV: Working Toward Solutions: Group Discussion of Hypothetical Post-Trial Scenarios (Moderator: Mark Barnes)

Download the Hypothetical Post-Trial Scenarios that will be discussed here.

Session V: Wrap Up (Moderator: Barbara Bierer)

Sponsored 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 and cosponsored by the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.