Ethical aspects
Ethical considerations of performing paediatric clinical trials
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Is it ethical to test medicines in children? Is it ethical not to, and thus expose children to the risks of either over or under-treatment? The legally binding United Nations Declaration of Rights of the Child states that “the child, by reason of his physical and mental immaturity, needs special safeguard and care, including appropriate legal protection before as well as after birth” (Link to Convention)
Many parents do not realise that 50% of medicines that European children take in hospital (90% in premature baby units) have not been especially licensed for them. Therefore errors and sadly sometimes deaths have occured as a result. Now there is a European Regulation that requires the testing of medicines in children by law, it is even more important that the research is conducted to the highest ethical standards.
Governments and regulators therefore have an awesome balancing act of responsibility. On one hand, they must encourage and compensate pharmaceutical companies in the performance of complicated and expensive paediatric clinical trials to ensure the safe, effective children’s medicines. On the other hand, volunteer parents and children need to be protected from any potential harm or perceived risk of economic exploitation.
The European Commission released a paediatric research ethical considerations document in February 2008. It is not strictly guidance as it is based on the Clinical Trials Directive which is implemented differently in each Member State. It aims to consolidate and expand paediatric trial good ethical practice. It needs clarification and there are several gaps but is an excellent first step.
It is very important to realise that this document applies to ALL paediatric clinical trials for medicines to be registered in Europe. As medicines are tested by pharmaceutical companies all over the world, there are very important ethical considerations. For example if a drug is being tested in a "developing country" where medicines are not free of charge, the parents may agree for their child to take part in a clinical trial just to have access to a paediatrician and free health check for their child. These are difficult and complex issues, especially around informed consent/assent and minimisation of risk and distress e.g. use of local anaesthetic cream to numb the skin for any blood tests.
Ethics Committees and Independent Review Boards (USA) are very strict about the reviewing of and giving permission for medicinal research on children to happen. They have to balance the risks and the benefits to both the individual child and children like them who have the same illness and need medicine that is safe and effective. Usually where studies are child and family friendly and conducted to high ethical standards, the recruitment rate for companies is generally higher and the medicine can get to market faster.
The Declaration of Helsinki is an international document produced by the World Medical Association who give ethical guidance to doctors and healthcare professionals who perform medical research. Unfortunately the latest revision in October 2008 is woefully inadequate. It makes reference to the protection of adults, those unable to consent for themselves, animals and the environment - but completely fails to address the research needs of chlldren, who are surely one of the most vulnerable groups in society.
If you are a pharmaceutical company or CRO planning a paediatric clinical trial and need an ethical feasibility report or help with an ethics committee application, or seek to identify practical and ethical considerations do get in touch and we would be pleased to help.