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Royal College of Paediatrics, Child Health: Ethics Advisory Committee;, and PROFESSOR SIR DAVID HULL
Guidelines for the ethical conduct of medical research involving children
Arch Dis Child 2000; 82: 177-182 [Full text] [PDF]
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[Read eLetter] Guidelines for the ethical conduct of medical research involving children
William Tarnow-Mordi   (2 June 2000)

Guidelines for the ethical conduct of medical research involving children 2 June 2000
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William Tarnow-Mordi,
Professor of neonatal medicine
University of sydney

Send letter to journal:
Re: Guidelines for the ethical conduct of medical research involving children

williamt{at}westgate.wh.usyd.edu.au William Tarnow-Mordi

Dear Editor:

While strongly supporting this document, I think that its recommendation that research in children should not simply duplicate earlier work is open to misinterpretation.

Many randomised studies in paediatrics are too small and under powered to provide conclusive results. (1, 2) Meta analysis of multiple similar studies provides a useful tool for overcoming the limitations of inadequate sample size. Systematic reviews often fail to draw clear conclusions because meta analysis is based on inadequate numbers of patients. When this is so, the only way forward may be to randomise further patients.

I would like to suggest that the recommendation be modified to read that research in children should not simply duplicate earlier work which is already conclusive.

References

1. Campbell H, Surry SAM, Royle EM, A review of randomised controlled trials published in archives of disease in childhood from 1982- 96. Arch Dis Child 1998;79:192-7

2. Tarnow-Mordi, WO, Healy MJ. Distinguishing between "no evidence of effect" and "evidence of no effect" in randomised controlled trials and other comparisons. Arch Dis Child 1999;80:210-1.

William Tarnow-Mordi
Professor of Neonatal Medicine
Westmead and New Children's Hospitals
University of Sydney
Australia

 

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