Ethical challenges of pediatric drug research

The Paediatric Regulation intends to integrate children better into the normative concept of drug supply. The Regulation changes the role of children, parents, physicians and researchers as well as regulators and industries. While there is generally no doubt that children have a right to receive scientifically proven drugs, the required clinical trials induce ethical concerns. Legitimate trials require a direct benefit for the group of patients. In addition, the intended trial with minors has to be the only way to answer the scientific questions. Conflicts between moral obligations as the treating physician and those as the researcher are foreseeable and relevant. In this context, the concept of equipoise - which means a true uncertainty about the clinical benefit of an intervention - becomes relevant and has implications on trial designs as well as informed consent and assent procedures.