Potential clinical impact of taking multiple blood samples for research studies in paediatric oncology: how much do we really know?
Pediatr Blood Cancer
; 46(7): 723-7, 2006 Jun.
Article
em En
| MEDLINE
| ID: mdl-16007598
ABSTRACT
Pharmacological studies of anti-cancer agents in children are essential to determine their clinical safety and efficacy, both of which can differ considerably from that observed in adults. However, the potential clinical impact of taking blood samples, in addition to those required for standard clinical practice is commonly a concern for both medical and allied staff and parents. Frequently quoted 'safe limits' of 3%-5% of total blood volume taken on any one study day are not based on published data and may not be acceptable for all patients. This article reviews some of the reasons why clinical pharmacology data for anti-cancer drugs is often lacking in a paediatric patient population, summarises data from a retrospective study investigating the potential impact of repeated blood sampling for research purposes and discusses how this issue may be more systematically addressed in future studies. Research involving children with cancer should be limited to those studies addressing key scientific questions and should be designed to limit both the number and volume of blood samples required.
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Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Hemoglobinas
/
Coleta de Amostras Sanguíneas
/
Ensaios Clínicos como Assunto
/
Gestão da Segurança
/
Neoplasias
Tipo de estudo:
Guideline
/
Observational_studies
/
Risk_factors_studies
Limite:
Adolescent
/
Child
/
Child, preschool
/
Humans
/
Infant
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2006
Tipo de documento:
Article