New medicines must be tested before they can be used in humans. This is true also for old medicines to be used on new indications. Clinical trials in healthy volunteers and in relevant patient groups, including children, are mandatory. After several preclinical tests the drug must pass a number of stages in a clinical development program that may take 10 years to pursue (for new drug candidates). All clinical trials are strictly regulated by law and must pass several regulatory evaluations before approval. The trials must be performed according to international regulations and are evaluated scientifically to ensure safety for those who participate in the trial.
The Medical Products Agency Sweden grants permission to carry out the trial after an evaluation. Further, approval must be granted by the Committee on Medical Research Ethics.
An informed consent is needed to be signed by the participants (children, depending on the age of the child and/or parents/guardians). The child’s own opinion must be considered and obeyed taking into account his/her age and level of understanding.