Clinical research in developing countries

Globalisation concerns an increasing number of human activities, namely research activities where projects involve parties not only at national or international level but also at world-wide level.

Because this globalisation occurs in a very heterogeneous world, because extreme wealth and poverty coexist, and injustice is a fact, the relationship between parties is not per se fair and rules must be defined to avoid exploitation and increasing injustice. Among the ethical issues to be considered, consensus exists on questions like the publication of results (even negative ones), or the need to address orphan diseases and poverty-linked diseases which are found only in developing countries. But other issues remain controversial namely:

• Under what conditions is the use of a placebo acceptable?
• When testing the efficiency of a new drug, should it be compared always with the best proven treatment even when this is usually not available in the country where the trial takes place, or should the best available treatment be used?
• Are there universal values and are they applicable whatever is the socio-cultural context?