Open AccessMechanisms for sustainable post-trial access: A perspective
Author(s) -
Poobalan Naidoo,
AUTHOR_ID,
Virendra Rambiritch
Publication year - 2021
Publication title -
south african journal of bioethics and law
Language(s) - English
Resource type - Journals
ISSN - 1999-7639
DOI - 10.7196/sajbl.2021.v14i3.782
Subject(s) - clinical trial , market access , authorization , business , revenue , perspective (graphical) , resource (disambiguation) , medicine , finance , ecology , computer network , computer security , pathology , artificial intelligence , computer science , biology , agriculture
Clinical trials are essential to establish the safety and efficacy of investigational products, contributing to risk/benefit assessments that ultimately determine whether these products meet the criteria for market authorisation. Clinical trials are also an important source of revenue and expertise generation for countries in which they are conducted. In developing countries, they represent substantial foreign direct investment. In spite of the substantial capital input that clinical trials require, the issue of funding post-trial access to beneficial therapies remains contentious, especially in resource-limited settings. In this article, we explore this situation and propose mechanisms to establish ‘win-win’ situations where both patients and clinical trial sponsors derive benefit from post-trial access programmes in low- and middle-income countries.