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Risk and benefit from clinical trials in minors:Making the case for transparent and consistent publications

Open Journal of Pediatrics 2013年第2期3卷 151-164页

作者： Andreas Dirk Henschel Lillian Geza Rothenberger Dominik Schrey joachim gerβ Georg Hempel joachim Boos Department of Pharmaceutical and Medical Chemistry—Clinical Pharmacy University of MünsterMünsterGermany Department of Paediatric Haematology and Oncology University Children’s Hospital MünsterMünsterGermany Institute of Ethics and History in Medicine Center for MedicineSociety and PreventionUniversity of TuebingenGermany The Royal Marsden Hospital Department of Paediatric OncologySurreyUK Institute for Biostatistics and Clinical Research University of MuensterGermany Department of Pediatric Hematology and Oncology University Children’s HospitalMuenster Albert-Schweitzer-CampusMuensterGermany

Rationale, aim and objectives: The European (EU) regulation on medicinal products for pediatric use (EC 1901/2006), which became effective in 2007, aimed to stimulate the clinical testing of medications in minors in order to reduce off-label use. In consequence, the number of minors taking part in randomized controlled clinical trials (RCTs) is likely to increase. Clinical trials in minors require a complex methodological design, a careful consideration of risks and benefits and a high level of ethical reflection. Unfortunately, as to the quality of clinical trials and their publications in minors little is known. Therefore, we assessed published reports of randomized, controlled clinical trials in minors, focusing on a common disease (asthma) and a defined spectrum of lifethreatening diseases (malignant diseases). Method: In an exploratory design, we scanned the publications for methodological aspects as well as indicators of ethical soundness, e.g., statements that informed consent had been obtained before the start of the trial or that a Data and Safety Monitoring Board ensured the patients’ safety during the trial. We also looked for passages reflecting the debate on equipoise or other forms of weighing risks and benefits. Results: We found that many of these aspects, which according to the scientific literature and generally acknowledged guidelines are essential to ensure good-quality trials and trial reports, were not considered in the publications analyzed. Conclusion: Therefore, we call for a more transparent and consistent presentation of the trials, especially of safety aspects, relying on a more critical and transparent ethical reflection.

关键词： Clinical Trials Minors SIGN CONSORT Ethics

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