Clinical trials that test medicines for use in the European Union (EU) increasingly take place in low and middle income countries. Most trial participants in these countries are poor, have limited access to health care and have low medical literacy, all factors that limit their autonomy to participate in the clinical trial. Unfortunately, the bodies responsible for protecting the rights and safety of these vulnerable participants, such as national drug regulatory authorities and ethics committees, often do not function properly.
This briefing paper provides an overview of known examples of unethical clinical trials. It was prepared by SOMO, in collaboration with Wemos, and is based on secondary sources. Although the focus is on developing countries, it also includes a few cases from the US and Europe. By providing such an overview, the paper aims to illustrate problems in the ethical conduct of clinical trials. It does not provide an analysis of clinical trials in general or of the scale of ethical violations. Indeed, the scale of the problem is unknown, because it cannot be estimated how many unethical clinical trials escape public attention and therefore remain unnoticed.
There are some indications that underlying structural problems exist, though, as in several of the trials described in this paper, the operations of pharmaceutical research companies were not adequately controlled or authorities seemed unwilling to address unethical drug testing even after it caught media attention.