Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Ethical aspects

    Ethical considerations of performing paediatric clinical trials

        Parents will be concerned that their children receive proven safe and effective medicines

    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 tested or 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, the research needs of volunteer parents and children need to be respected by carefully balancing the risks and benefits of the proposed research.

    Good Ethical Practice (GEP © Paediatric Research Consultancy 2011-13) We strongly recommend that Good Ethical Practice is treated by Sponsor companies in the same meticulous way they appy Good Clinical Practice (GCP) . Ethics are not a hurdle, but a companion and friend to good research. Not just theory at the Ethics Committee Application stage and a quick paragraph in the protocol, but an integral part of planning and clinical trial performance.  In addition, European Medicine Agency inspections include a requirement for good  ethical as well as good GCP conduct - especially if clinical trials are performed in Emerging countries or financially deprived communities in otherwise affluent areas.  If a good ethics section is in place in the protocol, it will be easier for monitors and inspectors to measure standards of current practice at the study site. The benefits of Good Ethical Practice include a smoother ethics committee reveiw (saving companies time and money) and increased recruitment & compliance as the research needs of children and their families are more likely to be taken into consideration.
    We therefore suggest GEP should include

    • A detailed section in the clinical trial protocol outlining ethical issues, how they will be addressed with how any relevant  law or ethics guidance for each item applies
    • Detailed Standard Operating Procedures outlining  how requirements of  Good Ethical Practice will be implemented and maintained in-house and at Investigator Sites etc
    • Regular ethics training  for all involved in paediatric (and any) clinical trials - GEP is for everyone!
    • Regular monitoring of ethical issues by Ethics and Compliance, QA departments and Data Safety Monitoring Boards

    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 important to realise that this document applies to ALL paediatric clinical trials for medicinal registration in Europe, wherever they are conducted. 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.

    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 makes reference to the protection of adults, those unable to consent for themselves, animals and the environment - but fails to address the research needs of chlldren.

    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.

    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 please  get in touch  and we would be pleased to help.

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