Accepted principles for conducting clinical trials in humans are based on the protection of human rights and human dignity regarding the use of biology and medicine, as reflected in the text of the Declaration of Helsinki. The protection of clinical trial subjects is ensured by risk assessment based on the results of toxicological tests performed prior to any clinical trial, reviews by medical ethics committees and competent authorities of Member States, as well as on the rules on personal data protection.
The conduct of clinical trials in the European Union (EU) has changed significantly since the entry into application of the Clinical Trials Regulation (EU) No. 536/2014 on 31 January 2022.
A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS). The map is designed to provide patients and healthcare professionals with easy access to comprehensive, real-time information about clinical trials conducted in their area, increasing access to clinical research in the European Union.
