New ethical guidance for paediatric clinical trials

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials.

The guidance, called ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, offers advice to institutional review boards (IRBs) and the industry at large when deciding whether to include children in studies about drugs, biological products and medical devices. The paper defines a framework for protecting children in clinical research, evaluates the risks and benefits, the scientific necessity of including children in research and parental and child consent.

In decades past, the industry has intentionally left children out of clinical trials in a bid to protect their wellbeing. However, this has meant that potentially breakthrough data has not been collected.

Thus, numerous drugs and medical devices approved and licensed by the FDA are missing essential paediatric-specific information on their product labels.

Instead, doctors have had no choice but to use and prescribe suitable products which unfortunately, have not been assessed for safety or efficacy by the FDA. Research professionals aware of this problem have identified that the paediatric population can be given targeted, more effective treatment by being involved in clinical investigations.

“Children need access to safe and effective medical products and health care professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who cannot provide consent for themselves and are afforded additional safeguards when participating in a clinical investigation,” stated Dr Dionna Green, Director at the FDA’s Office of Paediatric Therapeutics, which formed the guidance. Other organisations involved in compiling the guidance were the Centre for Drug Evaluation and Research, the Centre for Biologics Evaluation and Research and the Centre for Devices and Radiological Health.

“The best way to provide children with safe and effective treatment options is by including them in clinical research and providing these additional safeguards to protect them during clinical trials,” added Dr Green.