Regulations of Clinical Trials

Pediatric clinical trials are regulated by strict laws and ethical guidelines as the society and adults are in a position to protect children. As to clinical trials, children are an especially vulnerable group that should be protected from any unnecessary risks and stress.

Clinical trials for this group are limited, and children must not be exposed to any unnecessary risks. Moreover, the legal position of this particular group as minors must be taken into account. This means that the child is dependent on his or her guardian(s) and is unable to assess the significance and possible risks and stress of clinical trials.

Clinical trials are strictly regulated by international, national and European legislation, regulations, recommendations, guidelines, and declarations in order to ensure that trials are conducted respecting basic rights, human rights, the principle of voluntariness, and good clinical practice. By regulations, it is possible to supervise respective legal status and security of study subjects and to minimize the risks of clinical trials.

The most significant legal change was the EU Paediatric Regulation which came into force on January 26, 2007 concerning all EU member states. With the help of the regulation there will be more suitable, studied and safer medicinal products available to children in the future.

All relevant pediatric clinical trial related legal documents, such as regulations and guidelines, see more: Resources.