"Post-Trial Access to Medicines: Responsibilities and Implementation"


Thursday, September 18, 2014, 8:00am to 5:00pm


Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave., Cambridge, MA

Registration for the conference is almost closed! Register online.
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:

  1. How are recommendations regarding post-trial responsibilities influenced by the trial phase and/or prior experience with the intervention?
  2. 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.?
  3. What is a reasonable duration for post-trial responsibilities to extend?
  4. 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 will bring together diverse stakeholders to address some of these questions.

  • To discuss implications of international guidance on post-trial responsibilities for clinical research sponsors, governments, investigators, and other stakeholders
  • To articulate and understand the range of perspectives on post-trial responsibilities
  • To draw lessons from successful and unsuccessful attempts to implement post-trial access policies
  • To discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward
  • To identify key priorities for a Post-Trial Responsibilities Working Group to be launched by the Multi-Regional Clinical Trials Center at Harvard

The full agenda is now available on our website.
Please make sure to read the Hypothetical Post-Trial Scenarios prior to the event.
Cosponsored with the Multi-Regional Clinical Trials Center at Harvard University.