Failures in Clinical Trials in the European Union:Lessons from the Polish Experience
Streszczenie
When discussing the safety of research subjects, including their
exploitation and vulnerability as well as failures in clinical research, recent commentators
have focused mostly on countries with low or middle-income economies.
High-income countries are seen as relatively safe and well-regulated. This article
presents irregularities in clinical trials in an EU member state, Poland, which were
revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many
European Union regulations, including European Commission directives concerning
Good Clinical Practice, these irregularities occurred. Causes as well as potential
solutions to make clinical trials more ethical and safer are discussed.
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