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Pediatric clinical studies appear prone to bias, Hopkins review shows
Date:7/11/2010

ated to trial design and execution. Therefore, the investigators say, registering pediatric trials in the public domain will not only increase transparency but, in the long run, improve the validity of their results. In 2005, the International Committee of Medical Journal Editors called for registering all medical trials involving human subjects with www.ClinicalTrials.gov, a massive public repository of more than 70,000 trials from all over the world. However, less than 60 percent of the pediatric trials in the review were registered there.

The researchers also found that most of the trials (57 percent) either failed to use proper techniques that ensure anonymity or "blinding" to the type of treatment a patient gets, or they failed to clearly describe these techniques. The technique, called allocation concealment, ensures that neither the researcher nor the patient can guess which treatment they will get. The method also helps ensure that the treatment of one subject will not reveal to either scientists or the patients clues about the treatment of the next subject. Trials involving behavioral therapies were four times more likely to have this problem.

Overall, nearly 20 percent of the trials used improper masking techniques to ensure that neither the patient nor the researchers know which treatment went to which patient.

The 146 trials in the review appeared between 2007 and 2008 in the five leading pediatric journals Pediatrics, Pediatric Infectious Diseases, Journal of Pediatrics, Archives of Pediatrics and Adolescent Medicine and the Journal of the American Academy of Child and Adolescent Psychiatry and the three highest-ranked general medical journals JAMA, The New England Journal of Medicine and The Lancet.


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Contact: Ekaterina Pesheva
epeshev1@jhmi.edu
410-516-4996
Johns Hopkins Medical Institutions
Source:Eurekalert

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