clinical trials in children, for children

clinical trials in children, for children - Editorial...

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Editorial www.thelancet.com Vol 367 June 17, 2006 1953 Clinical trials in children, for children A new era for research in children is about to begin, and should be welcomed. On June 1, the EU Parliament announced draft amendments to the EU Medicines for Children legislation which pave the way for more clinical trials of paediatric prescribing. The goal is to provide age-specific evidence to improve the safety and e ffi cacy of medications used for children. Such a move is overdue. In 1990, the UN Convention on the Rights of the Child declared that “children have the right to good quality health care—the best health care possible”. Yet, the basis on which health-care decisions are made for children has often relied on extrapolation from adult studies with limited generalisability. Policy changes to encourage the involvement of children in research were requested by the EU Health Council in 2000, and similar alterations were incorporated in the 2001 US Food and Drug Administration (FDA) Modernization Act. However, even the UK Department of Health’s National Service Frameworks, which set standards for evidence- based care within the NHS, contain a proviso that not all aspirations in the framework for children are supported by evidence. Clearly, to ensure that children receive the
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