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Children are pharmaco‐therapeutic orphans

Children are pharmaco‐therapeutic orphans ‘Drugs must be studied in children to determine their safety and efficacy in this age group. Growth, differentiation and maturation may alter the drugs’ responses in the newborn, infant, child or adolescent. The pharmacokinetic, pharmacodynamic and toxic properties of drugs cannot be predicted from studies in adults. There is a moral imperative to formally study drugs in children so that they can enjoy equal access to existing as well as new therapeutic agents.’ (AAP Guidelines 1995). Many years ago one of us published an article on the value of participating in an asthma trial ( 1 ). At that time the reason for publishing was that a series of trials which we had conducted had generated a very high placebo response. We proposed that much of the beneficial effect of participating in the trial was a consequence of attention to detail which accompanies studies. The patients are seen regularly and frequently usually by the same doctor who has a special interest in the condition and a personal interest in ensuring that patients are sustained in the study. This in relation to asthma particularly focuses on extra training in optimal techniques in using the inhalation devices and in ensuring http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Pediatric Allergy and Immunology Wiley

Children are pharmaco‐therapeutic orphans

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References (18)

Publisher
Wiley
Copyright
© 2010 John Wiley & Sons A/S
ISSN
0905-6157
eISSN
1399-3038
DOI
10.1111/j.1399-3038.2010.01044.x
pmid
20444165
Publisher site
See Article on Publisher Site

Abstract

‘Drugs must be studied in children to determine their safety and efficacy in this age group. Growth, differentiation and maturation may alter the drugs’ responses in the newborn, infant, child or adolescent. The pharmacokinetic, pharmacodynamic and toxic properties of drugs cannot be predicted from studies in adults. There is a moral imperative to formally study drugs in children so that they can enjoy equal access to existing as well as new therapeutic agents.’ (AAP Guidelines 1995). Many years ago one of us published an article on the value of participating in an asthma trial ( 1 ). At that time the reason for publishing was that a series of trials which we had conducted had generated a very high placebo response. We proposed that much of the beneficial effect of participating in the trial was a consequence of attention to detail which accompanies studies. The patients are seen regularly and frequently usually by the same doctor who has a special interest in the condition and a personal interest in ensuring that patients are sustained in the study. This in relation to asthma particularly focuses on extra training in optimal techniques in using the inhalation devices and in ensuring

Journal

Pediatric Allergy and Immunology – Wiley

Published: Mar 1, 2010

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