Clinical Drug Trials in Ukraine

Myths and Realities

For strategic reasons and to maximise profits, industry‐sponsored clinical drug trials on human subjects are increasingly offshored in developing and emerging countries. In those countries, pharmaceutical companies can find a large pool of vulnerable people willing to take part in drug trials as it represents often their only treatment option. In addition, weak regulatory environments enable the pharmaceutical  multinationals to shorten clinical trials duration. This increases significantly  the risk of ethical violations. Concerned about this situation, the Berne Declaration launched  several investigations in 2012 and 2013. Four field studies took place in Argentina, India, Russia and Ukraine to better understand these contexts in which numerous clinical trials take place. How is the regulatory system performing? Are the ethical standards respected? How do Swiss firms conducting clinical trials behave in these countries?