Focus Area: Clinical Trials & Research

A Conference on Post-Trial Responsibilities: Ethics and Implementation

MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School 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:

  1. 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)
  2. 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)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

A Conference on Post-Trial Responsibilities: Ethics and Implementation

September 18, 2014 @ 7:30 am – 5:30 pm

Harvard Law School, Wasserstein Hall, Millstein East, Cambridge, MA

The objectives of the conference were to discuss implications of international guidance on post-trial responsibilities for clinical research, to articulate and understand the range of perspectives on post-trial responsibilities, to draw lessons from successful and unsuccessful attempts to implement post-trial policies, and to discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward.

For more information please see links below.

2014-09-18–Proceedings – Post Trial Access Conference

2014-09-18–Agenda Post Trial Access Conference

Deliverables

Projects

Declaration of Helsinki comments: Declaration of Helsinki, issued for public comment by the Counsel of the WMA in April 2013

MRCT Center at Harvard responded to the World Medical Association’s request for comments or potential revisions to the Declaration of Helsinki (DoH), which will reach its 50th anniversary in 2014.

To maintain its relevance and prominence as a guidance document for clinical research, revisions are frequently made to the DoH. Revisions for the 50th Anniversary will be published in 2014. Staff, sponsors, and academic affiliates of the MRCT Center collaborated to submit the attached comments to the World Medical Association.

Comments are available here

Comments on Declaration of Helsinki