Mechanisms for sustainable post-trial access: A perspective

被引:3
作者
Naidoo, P. [1 ]
Rambiritch, V. [2 ]
Webb, D. A. [3 ]
Leisegang, R. F. [4 ]
Cotton, M. F. [5 ]
Etheredge, H. R. [6 ,7 ]
机构
[1] King Edward VIII Tertiary Hosp, Dept Internal Med, Umbilo, South Africa
[2] Univ KwaZulu Natal, Biomed Res & Eth Comm, Durban, South Africa
[3] Houghton House Addict & Mental Hlth Treatment Cen, Johannesburg, South Africa
[4] Uppsala Univ, Dept Pharmaceut Biosci, Uppsala, Sweden
[5] Stellenbosch Univ, Fac Med & Hlth Sci, Dept Paediat & Child Hlth, Cape Town, South Africa
[6] Univ Witwatersrand, Fac Hlth Sci, Wits Donald Gordon Med Ctr, Johannesburg, South Africa
[7] Univ Witwatersrand, Fac Hlth Sci, Dept Internal Med, Johannesburg, South Africa
关键词
RESEARCH PARTICIPANTS; HEALTH-CARE;
D O I
10.7196/SAJBL.2021.v14i3.782
中图分类号
R-052 [医学伦理学];
学科分类号
0101 ; 120402 ;
摘要
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.
引用
收藏
页码:77 / 78
页数:2
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