Ethical issues in clinical trials in paediatrics

Abstract

It is a common practice among doctors that they prescribe off-label drugs to children. When doctors prescribe medicines in this way, they are prescribing medications that are not licensed for the use in children. This practice is the result of the lack of clinical research in the paediatric population. Although this way of prescribing used to be successful, however, this is not the best practice since this may lead to various unexpected adverse reactions which may be dangerous too. Therefore, it is important that clinical studies in the paediatric population be carried out so the use of such medicines that already exist but not licensed for the use in children will be scientifically proved and new medicinal products for the use in such population will be available too. Following several unethical cases in research in humans, especially during World War II, several declarations, codes, regulations and guidelines were drafted so research in humans is carried out in an ethical way. When research is done ethically, this assures that the research subjects are not exploited, and their rights are safeguarded, and such results are valid and not manipulated. Children are considered as vulnerable, so it is important that when clinical research is conducted in this population, children are given special protection. Conducting clinical trials in children is not the same as conducting clinical trials in adults. This difference is not only in the design itself of the trial but also how decisions are taken during the different stages of the study. Thanks to several incentives there was an increase in clinical trials conducted in children, and thanks to the several declarations, codes, regulations and guidelines, children are protected when they are enrolled in research. On the other hand, although there were many advancements in this area still there is room for improvement.