Clinical research and trials in developing countries

Abstract

Over 80 per cent of the global disease burden occurs in developing countries. Yet the proportion of research conducted in these countries is less than 10 per cent of the global research activity. This article emphasizes the need to conduct research in developing countries on locally relevant questions, provides general principles that may assist in establishing such studies, and describes some experiences in the cardiovascular area.

Cardiovascular clinical trials in Africa: opportunities and challenges

“…(37) There have also been numerous instances where pharmaceutical companies have attempted to pursue clinical trials in developing countries which would not be considered ethical or practical in a developing country. (38) A good example of this is the Trovan meningitis study in Nigeria during 1996. (23) Emanuel has identified three controversial issues with regards to the conduct of clinical trials in developing countries that need to be addressed, namely the standard of care to which investigational treatments should be compared, the "reasonable availability" of proven interventions demonstrated to be beneficial during the study, and the "quality of the informed consent" process.…”

“…sites. (38) These can impact heavily on the conduct of the trial and hence the integrity of the data. In some cases, safety of site personnel can also be problematic.…”

“…(22,38) In addition, it is important that sponsors obtain the commitment, support and understanding of local leaders, health workers and their customs. (38) Care must be taken to ensure that the project is not perceived as "exploitative".…”

“…(22,38) In addition, it is important that sponsors obtain the commitment, support and understanding of local leaders, health workers and their customs. (38) Care must be taken to ensure that the project is not perceived as "exploitative". (38,39) ■ Suitability of clinical research to the population: There are ethical concerns about researching drugs in a community in which the sponsor has no intention of marketing the drug.…”

“…(38) Care must be taken to ensure that the project is not perceived as "exploitative". (38,39) ■ Suitability of clinical research to the population: There are ethical concerns about researching drugs in a community in which the sponsor has no intention of marketing the drug.…”