Clinical Trials in Children

Pharmaceutical Medicine - Tập 21 - Trang 121-129 - 2012
Sergio G. Golombek1, John van den Anker2,3, Klaus Rose4
1The Regional Neonatal Center, Maria Fareri Children’s Hospital at Westchester Medical Center/New York Medical College, Valhalla, USA
2Children’s National Medical Center, Washington, USA
3Sophia Children's Hospital, Rotterdam, The Netherlands
4F. Hoffman La Roche Pharmaceuticals, Basel, Switzerland

Tóm tắt

Ethical concerns and paediatric clinical trials go hand in hand. Without knowledge on how to overcome ethical challenges, companies will struggle to develop drugs for the paediatric population. This article reviews the ethical hurdles of paediatric research and offers some strategies to overcome these challenges. It also describes the basic principles of medical ethics, discusses ethical issues unique to children, the benefit-risk balance of research in children, off-label uses and US and EU legislations regarding paediatric research.References

Tài liệu tham khảo

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