Child versus adult research: The gap in high-quality study design
ABSTRACT The objective of this study was to determine whether there were differences in study design and purpose between published child- and adult-focused clinical research.
We reviewed all articles published in the New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, Pediatrics, Archives of Internal Medicine, and Archives of Adolescent and Pediatric Medicine during the first 3 months of 2005 and assessed each study's design and purpose. We compared articles focused on adults with those focused on children.
We included 370 original research reports in our analysis (New England Journal of Medicine, n = 46; Journal of the American Medical Association, n = 60; Annals of Internal Medicine, n = 27; Pediatrics, n = 130; Archives of Internal Medicine, n = 73; Archives of Adolescent and Pediatric Medicine, n = 34), of which 189 included only adults as subjects and 181 only children. Among adult studies, compared with child studies, there were more randomized, controlled trials (23.8% vs 8.8%) and systematic reviews (10.6% vs 1.7%) and fewer cross sectional studies (16.9% vs 40.9%). Study purposes also varied, with studies of therapies constituting 38.1% of adult studies, compared with 17.7% of child studies. In contrast, epidemiological studies, defined as studies describing the prevalence or incidence of diseases or risk factors or showing associations between risk factors and diseases, constituted 6.4% of adult studies, compared with 26.5% of child studies.
In 6 leading generalist and specialist journals, studies involving adults were significantly more likely than child studies to be randomized, controlled trials, systematic reviews, or studies of therapies. If such studies are to be viewed as the highest possible quality of evidence, then this difference has implications for quality of care for children and for funding and future directions in clinical research involving children.
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ABSTRACT: The greatest burden of disease in children lies in the developing world; however, previous reviews have suggested that few randomized controlled trials (RCTs) involving children take place in developing countries. Children in developing countries deserve the same standard of medicines as those in developed countries, i.e. appropriate medications for the specific diseases that occur. To elucidate published pediatric therapeutic RCTs that have taken place in the developing world and to determine whether they are appropriate for the major diseases occurring there, and to explore their approach to safety monitoring. A previously assembled database of pediatric RCTs published between 1996 and 2002, from journals indexed in MEDLINE, was analyzed. The main country of setting of the RCTs was categorized as having low, medium or high development status according to the Human Development Index (HDI). Articles were read to add the WHO International Classification of Diseases 10th Revision (ICD-10) category of the disease studied, the WHO Collaborating Centre for Drug Statistics Methodology Anatomical Therapeutic Chemical (ATC) classification system category of the main drug therapy studied, the source of funding, and ethical approval to the variables already recorded in the database. One hundred and fifty-eight (22%) of the 733 RCTs analyzed took place in medium and low HDI (developing) countries. The disease areas studied seemed appropriate, with 89 (56%) of the 158 RCTs studying infectious and parasitic diseases. Ninety-nine (63%) RCTs from developing countries were trials of antiparasitic and anti-infective drugs. Compared with studies from high HDI countries, a significantly lower proportion of articles from medium and low HDI countries mentioned ethical committee or institutional review board approval, and safety monitoring. Only one paper from low and medium HDI countries mentioned the presence of a safety monitoring committee/data safety monitoring board. Published pediatric drug RCTs conducted in developing countries appear to study appropriate diseases but the results show that fewer RCTs are undertaken compared with the developed world. The standard of reporting for RCTs from developing countries needs attention to ensure that adequate information can be obtained, especially with regard to safety monitoring.Paediatric Drugs 04/2010; 12(2):99-103. DOI:10.2165/11316260-000000000-00000 · 1.72 Impact Factor