Taking post-trial obligations seriously

This project explores the current status quo of post-trial obligations in developing countries, specifically the Philippines, of clinical trial sponsors from the European Union.

About the project

Multinational clinical trials are increasingly being held in developing countries and in relation to it, international ethics guidelines have proposed post-trial access (PTA) as a form of compensation. This requires sponsors, investigators, and governmental agencies to make the product or the knowledge gained through the clinical trial available to the participants, the research community, or the host country. However, PTA has not trickled down to actual clinical trials. This is largely because what PTA is has never been concretized. To address this issue, I wish to examine and ethically reflect on what post-trial access is a requirement of, from whom, and on whose oversight it falls.

To effectively address this objective, both empirical research and ethical reflection shall be used. Focus group discussions and a stakeholder meeting in Norway and the Philippines, representing the sponsor and the host countries respectively. This will be followed by a more systematic ethical reflection on the questions of what PTA is a requirement of and what the duties are of duty-bearers within the context of an ethics of human rights. At the end, I aim to develop an integrative guidance document on the provision of PTA in developing countries.

Objectives

In response to the problem outlined above, the main objective of this proposal is as follows: to examine what is meant by post-trial access in terms of what it is a requirement of, from whom, and on whose oversight it falls.

To address the main objective, the sub-objectives are as follows:

  1. Explore current practice and realistic possibilities of PTA in terms of what may be provided to whom, by whom, and whose oversight it falls;
  2. Ethically reflect on what PTA ought to be;
    • a. Provide a nuanced understanding of what PTA is in terms of what it is a requirement of, i.e., what must be provided, for how long, and to whom;
    • b. Ethically reflect on who ought to have PTO and what these obligations are;
    • c. Ethically reflect on who should be responsible for PTA oversight;
  3. Provide ethical guidance on what PTA ought to be a requirement of, to whom, by whom, and whose oversight it falls.

Financing

  • Scientia (Marie Curie) Fellowship

Start - finish

March 2017 to February 2019

Published Apr. 6, 2017 3:20 PM - Last modified Apr. 6, 2017 3:20 PM