Post-Trial Responsibilities: 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:
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Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefitting (whether between the end of the trial and product approval or indefinitely)
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Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
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Provision of the study intervention, other care, or other resources to the community in which the trial was conducted
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:
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How are recommendations regarding post-trial responsibilities influenced by the trial phase and/or prior experience with the intervention?
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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.?
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What is a reasonable duration for post-trial responsibilities to extend?
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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 brought together diverse stakeholders to address some of these questions.
Objectives:
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To discuss implications of international guidance on post-trial responsibilities for clinical research sponsors, governments, investigators, and other stakeholders
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To articulate and understand the range of perspectives on post-trial responsibilities
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To draw lessons from successful and unsuccessful attempts to implement post-trial access policies
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To discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward
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To identify key priorities for a Post-Trial Responsibilities Working Group to be launched by the Multi-Regional Clinical Trials Center at Harvard
Agenda:
7:30 - 8:00am Participants Arrive, Breakfast, and Registration
8:00 - 8:05am Welcome Remarks
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Mark Barnes (Ropes & Gray, MRCT)
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Barbara Bierer (MRCT)
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I. Glenn Cohen (Petrie-Flom, Harvard Law School)
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.
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8:15 - 8:35am Christine Grady (NIH) - The Ethics of Post-Trial Responsibilities: History, Models, Agreement, and Controversy
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8:35 - 8:55am Jeff Blackmer (University of Ottawa) - World Medical Association (WMA) Declaration of Helsinki – Process and Perspectives
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8:55 - 9:15am Alex John London (Carnegie Mellon University) - The Council for International Organizations of Medical Sciences (CIOMS) Approach
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9:15 - 9:35am Seema Shah (NIH) - Policy Approaches Around the Globe
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9:35 - 10:00am Panel Discussion and Q & A Panel and Audience
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
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10:15 - 10:35am Richard Klein (FDA) - FDA Perspective
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10:35 - 10:55am Daniel Wang (London School of Economics) - Governmental requirements
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10:55 - 11:15am Jocelyn Ulrich (PhRMA) - Industry perspective
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11:15 - 11:35am Ramadhani Noor - Investigator perspective
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11:35 - 11:55am Mitchell Warren (AVAC) - Participant/community perspective
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11:55 - 12:15pm Panel Discussion and Q & A Panel and Audience
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.
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12:45 - 1:05pm Joseph Millum (NIH) - NIH Global HIV Research Case Study
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1:05 - 1:25pm Nancy Padian (UC Berkeley) - Investigator Case Study
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1:25 - 1:45pm Walter L. Straus (Merck & Co.) - Industry Case Study #1
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1:45 - 2:05pm Laurie Letvak (Novartis) Industry Case Study #2
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2:05 - 2:35pm Panel Discussion and Q & A Panel and Audience
2:35 - 2:45pm Break
Session IV: Working Toward Solutions: Group Discussion of Hypothetical Post-Trial Scenarios (Moderator: Mark Barnes)
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2:45 - 3:00pm Objectives for panel discussion of scenarios Presentation of scenarios and key questions
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3:00 - 4:00pm Panel Discussion: Christine Grady, Mitchell Warren, and Richard Saver (UNC Law), and Luann Van Campen
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4:00 - 4:30pm Audience discussion
Download the Hypothetical Post-Trial Scenarios that will be discussed here.
Session V: Wrap Up (Moderator: Barbara Bierer)
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4:30 - 5:30pm Group discussion to identify key priorities for new Post-Trial Responsibilities MRCT Working Group
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.
Videos
VIDEO: Welcome Remarks; Session I: Setting the Stage; Christine Grady, Jeff Blackmer, Alex John London, and Seema Shah
Tags
bioethics clinical research health law policy intellectual property pharmaceuticals public health regulation