RAPS: Bioethics Council Calls for Reforms for Clinical Trials Involving Children
The Nuffield Council on Bioethics has released a report on the ethical issues surrounding clinical research involving children in the UK and EU. The report, which looks at the current status of clinical research and regulations, argues better regulation and greater involvement from children is critical to increasing the number of clinical trials involving children. Companies are often reluctant to conduct clinical studies on children due to ethical concerns and fear of adverse events during trials. However, conducting clinical research on children is critical to determining whether drugs are safe and effective in pediatric populations. Without adequate clinical data from pediatric patients, many drugs lack dose and safety information for children. Because children\'s bodies are inherently different from adults, they often react differently to medicines or require different doses. To encourage clinical research for pediatric medicines, authorities in the US and EU have offered incentives and guidance to companies that include children in their clinical programs.