Randomized Clinical Trials in Children -- Ethical and Methodological Issues
Henschel, A D
Rothenberger, L G
Current pharmaceutical design 2010; 16(22): 2407-15
Randomization is an internationally accepted methodological tool used to perform sound clinical research. To ensure the clinical value of medical interventions, both evidence based medicine and new drug approvals require that randomized controlled trials (RCT) be conducted. Randomization prevents the manipulation of participant allocation and balances unknown confounders in a way no other method can. The gold standard RCT, however, is complex to conduct and requires significant financial and structural resources. In consequence, drug development and registration are primarily driven by the pharmaceutical industry. Within the field of pediatrics, we need high quality research tailored to children in order to reduce off-label use and to ensure that we expose children only to effective and, above all, safe drug treatments. The American and European regulatory authorities now offer programs to support such studies and clinical researchers and pharmaceutical industries are obliged to put them into practice in the best interest of the children. Issues relating to feasibility as well as ethical issues must be born in mind when planning RCTs in child populations. Obtaining informed assent from children in an adequate manner is one of several key elements. Moreover, it is essential to ensure equipoise before conducting a trial. Thus, issues relating to acceptability can be addressed and the discrimination of treatment groups within RCTs can be prevented. This narrative review addresses ethical and methodological aspects of RCTs in adults and especially in children and includes a quantitative analysis, which explores issues relating to the publication of RCTs.
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The Importance of the Preservation of the Ethical Principle of Equipoise in the Design of Clinical Trials: Relative Impact of the Methodological Quality Domains on the Treatment Effect in Randomized Controlled Trials Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike (2003-10)Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control ...