Linked Life Data

11127842

Source:http://linkedlifedata.com/resource/pubmed/id/11127842

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2000-12-20
pubmed:abstractText
Recent initiatives by the US Congress and the Food and Drug Administration have provided effective incentives to develop new drugs for children leading to a dramatic increase in the number of paediatric clinical trials being done in the US. There also is increased international interest in development of pharmaceuticals for children as reflected in the draft International Conference on Harmonisation guidelines. The demands created by these initiatives are challenging the industry, regulators, and clinical investigator community. As the infrastructure for paediatric clinical research evolves, it is paramount that the ethical issues unique to children are not forgotten and that children do not become a commodity in the clinical trial economy. Furthermore, it is important to recognise that the adult paradigm for clinical research cannot simply be imposed on paediatric studies and that protocols must be appropriately designed for different age groups. Clinical studies can be, are being, and will continue to be successfully carried out in children on behalf of children so that ultimately children can benefit from therapeutic advances to the same extent enjoyed by their parents and grandparents.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1174-5878
pubmed:author
pubmed:issnType
Print
pubmed:volume
2
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
411-8
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:articleTitle
Clinical trials in children: problems and pitfalls.
pubmed:affiliation
Children's Mercy Hospital and University of Missouri-Kansas City, 64108, USA. rkauffman@cmh.edu
pubmed:publicationType
Journal Article, Research Support, U.S. Gov't, P.H.S.