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

Abstract

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.