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Regulatory News | 27 May 2015 | By Michael Mezher
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.
Despite efforts by governments and regulators, the number of clinical studies involving children remains low. To address this issue, the Nuffield Council on Bioethics, a UK-based organization whose mission is to examine and report on ethical issues related to biology and medicine, has issued a report examining the ethical issues surrounding clinical research involving children.
In the UK, clinical trial proposals are reviewed by National Health Service (NHS) Research Ethics Committees (RECs). According to the Nuffield report, REC members said they often "feel anxious about approving research with children." To address this issue, the review proposes establishing a network of pediatric experts to advice RECs on studies involving children. This, the authors argue, can help provide REC members with insights into "the risks and burdens … and areas where there is a lack of evidence," for children.
One major takeaway from the report is the value researchers and REC members can gain from listening to children's thoughts on proposed studies. The report points to Young Persons' Advisory Groups (YPAGs) in the UK, which are composed of 8-18-year-olds who give their opinions as to whether studies are "acceptable to children." This includes looking at study materials and obligations such as blood tests or days taken off school.
For children under 16 in the UK, the decision to take part in research is up to the child's parents. However, the report argues children under 16 should be involved in the decision to take part in research when possible.
In the EU, all new marketing authorization applications must "include the results of studies carried out in children of different ages," and follow a Paediatric Investigation Plan (PIP).
However, companies may receive deferrals where additional data is necessary to first establish the product's efficacy in adults, or waivers, if the condition the product is intended to treat does not affect children. The Nuffield report argues that the waiver system should be amended to require companies to conduct studies in children if a medicine intended to treat a disease in adults has the potential to treat other "related disorders" in children.
Additionally, the report calls for greater effort to be put into determining appropriate dosages of older, off-patent, medicines for children that were not required to follow a PIP under the current clinical trial regulations.
Nuffield Council on Bioethics Press Release, Report
Tags: Children, Clinical trials, Pediatric, Paediatric investigation Plan