Short Report

Mechanisms for sustainable post-trial access: A perspective

P Naidoo, V Rambiritch

Abstract


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.

Authors' affiliations

P Naidoo, Department of Internal Medicine, King Edward VIII Tertiary Hospital, Umbilo, South Africa

V Rambiritch, Biomedical Research and Ethics Committee, University of KwaZulu-Natal, Durban, South Africa

Full Text

PDF (63KB)

Cite this article

South African Journal of Bioethics and Law 2021;14(3):77. DOI:10.7196/SAJBL.2021.v14i3.782

Article History

Date submitted: 2022-01-28
Date published: 2022-01-28

Article Views

Abstract views: 1570
Full text views: 1473

Comments on this article

*Read our policy for posting comments here