Clinical trials in children

Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects...

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Vydáno v:British journal of clinical pharmacology Ročník 79; číslo 3; s. 357 - 369
Hlavní autoři: Joseph, Pathma D., Craig, Jonathan C., Caldwell, Patrina H.Y.
Médium: Journal Article
Jazyk:angličtina
Vydáno: England BlackWell Publishing Ltd 01.03.2015
Témata:
Child
clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - methods
Drug Evaluation - ethics
Drugs, Investigational - adverse effects
Drugs, Investigational - pharmacokinetics
Drugs, Investigational - therapeutic use
ethics
Ethics, Medical
Humans
medicines in children
paediatric drug therapy
Pediatrics - ethics
Pediatrics - methods
Research Design
Themed Section - Paediatric Prescribing
clinical trials
ethics
medicines in children
paediatric drug therapy
ISSN:0306-5251, 1365-2125, 1365-2125
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Popis
Shrnutí:Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non‐use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence‐based therapies in children.
Bibliografie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ObjectType-Review-3
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ISSN:0306-5251
1365-2125
1365-2125
DOI:10.1111/bcp.12305