Farida Lada, UNU-MERIT / School of Governance
Clinical trials are an essential part of the new drug development process, as they are necessary in order to demonstrate the safety and efficacy of new drugs for humans. Many stakeholders are involved in the oversight and implementation of clinical trials, which makes the governance of clinical trials a very complex process. Given the diverse agendas of the different stakeholders, it is not surprising to see both allegations of and proven cases of ethical violations related to the conduct of clinical trials. Such ethical violations have given rise to the field of protection of human subjects of clinical trials, which comprises of governance of clinical trials at three levels: i) international governance through the establishment of international standards; ii) national level governance through regulatory oversight; and iii) institutional governance through policies and procedures of the pharmaceutical company, the contract research organizations and the ethics committees. This thesis aims to address the question of how to maximize clinical trial subject welfare while promoting novel drug innovation. Using qualitative methods and concepts borrowed from game theory, this thesis develops a framework for evaluating clinical trial governance at the various levels. It then uses the framework to assess existing governance at national levels in the United States and India, as representative of traditional and emerging markets, respectively, as well as governance by industry players. Using the lessons learned from these evaluations, the thesis proposes a relationship structure inclusive of feedback mechanisms, which may improve the effectiveness of the governance of clinical trial. The thesis concludes with policy and strategy recommendations for use by the various stakeholders.
Venue: Aula, Minderbroedersberg 4-6, Maastricht
Date: 22 June 2016
Time: 16:00 - 17:30