Globalization of clinical trials: ethical and regulatory implications

Abstract

The globalization of clinical research is a relatively recent phenomenon, in which many of these studies are taking place on a global scale, with a significant increase of clinical trials in developing countries. The largest clinical trials average annual growth from 2005–2012 occurred in Asian (30%), and Latin American/Caribbean (12%) regions; other geographic regions had growth rates less than the world average (8%). The largest average annual growth occurred in lower-middle income (33%) and low-income (21%) regions. Emerging economies from low-middle income countries (Iran, China, Egypt) had the largest country-specific growth; other countries included South Korea, Japan, India, Brazil, and Turkey. With the globalization of clinical trials, it becomes necessary to strengthen legal and ethical guidelines for guaranteeing the research participants’ integrity. Some observers noted, more than a decade ago, that studies were being run in developing countries without concerns regarding adherence to the international ethical principles. The process of globalization of clinical trials, therefore, can be advantageous because, for example, it gives to access to new treatments to participants; however, it requires discussion and the monitoring of ethical questions related mainly to ensuring the integrity, welfare and safety of the research participant; to the frames of reference of bioethics, such as autonomy, nonmaleficence, beneficence, justice and fairness.