Ethical, clinical and practical considerations in designing clinical trials in pediatric psychopharmacology

摘要

Since the beginning of this new century, drug development is changing; the concern of protecting children against clinical research is fading away and a new paradigm, which is not yet necessarily accepted by all of society, is now emerging; that of protecting children through clinical research. It is unethical to withold available treatments from children because of lack of research, consequently it is expected that the number of pediatric clinical trials will increase in the future. However, research is not deprived of risks, and it is necessary to maintain a perfectly well-balanced, scientific and ethical approach when designing pediatric clinical trials. Child psychopharmacology provides an opportunistic paradigm of the difficulties and challenges of pediatric drug development. The hurdles of developing and conducting research in the pediatric population are numerous and some of them are more exacerbated in the field of child and adolescent psychiatry than in other pediatric areas such as pediatric oncology. Designing clinical trials in children requires taking into account specific ethical, clinical and practical pediatric considerations, and discussions on the issues of risk, benefit and burden should always be carried out on a single clinical trial basis.