Clinical Research & Clinical Trials

Globalization of clinical trials

The globalisation of clinical research is a relatively new phenomenon in which many of these studies are being conducted on a global basis, with a major increase in clinical trials being conducted in developing nations. From 2005 to 2012, the Asian (30%) and Latin American/Caribbean (12%) regions had the highest average yearly growth rates in clinical trials; other geographic regions had growth rates lower than the global average (8%). Lower-middle income (33%) and low-income (21%) regions saw the highest average annual growth. Emerging economies from low-middle income countries experienced the most country-specific growth, followed by South Korea, Japan, India, Brazil, and Turkey. With the globalisation of clinical trials, it is vital to strengthen legal and ethical criteria to ensure the integrity of study participants. Observers remarked more than a decade ago that research was being conducted in impoverished countries with no respect for international ethical guidelines. The process of globalisation of clinical trials can thus be advantageous because, for example, it provides participants with access to new treatments; however, it requires discussion and monitoring of ethical questions related primarily to ensuring the integrity, welfare, and safety of the research participant; to bioethical frames of reference, such as autonomy, beneficence, justice, and fairness.