Hidden risks associated with clinical trials in developing countries

Abstract

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems.

Comparative effect sizes in randomised trials from less developed and more developed countries: meta-epidemiological assessment

“…2 traditions in clinical research. 13 Firstly, publication dynamics and biases may differ. 14 Investigators in less developed countries may face a higher barrier against publication of "negative" results.…”

Estudo crítico do princípio de benefício e dano

“…Just as Lorenzo et al 13 proposed that clinical trials which are not related to the health priorities of the country in which they are performed should be charged a fee, so Ballantyne 26 proposed the creation of a global research tax. The money generated from this tax would not be distributed equally, but instead would be shared according to a principle called "maximin", where the benefits are maximized for those who are worse off, or the most vulnerable.…”

“…This was also the concern of Lorenzo et al 13 classification which is defined by a lack of income, information, knowledge and technology; a lack of access to public bodies and other social representation; a limited network of social relations; a diversity of beliefs and practices in relation to the society around one; old age and physical disabilities. Given the ineffectiveness of the latest versions of the DH to protect research subjects, the authors suggest the adoption of the UDBHR as a general framework document, recommending that each country creates, alone or with the support of trusted partners, its own resolutions and legislation.…”

Une industrie normée ? Gouvernement par les normes, jeu sur les normes et internationalisation des chaînes de valeur dans le secteur pharmaceutique

“…Ce sont souvent des médicaments associés aux pathologies des pays développés qui sont testées auprès de populations de pays en voie de développement dont les caractéristiques diffèrent, ce qui est source de biais potentiels (Lorenzo et al, 2010). Les sujets des essais cliniques sont issus des populations les plus démunies, le plus souvent illettrées (Shuchman, 2007) 55 .…”