Many drugs used in paediatric medicine are off-label. There is a rising call for the use of adaptive clinical trial designs in responding to the need for safe and effective drugs given their potential to offer efficiency and cost-effective benefits compared with traditional clinical trials. ADs have a strong appeal in paediatric clinical trials given the small number of available participants, limited understanding of age-related variability and the desire to limit exposure to futile or unsafe interventions. Although the ethical value (...) of adaptive trials has increasingly come under scrutiny, there is a paucity of literature on the ethical dilemmas that may be associated with paediatric adaptive designs. This paper highlights some of these ethical concerns around safety, scientific/social value and caregiver/guardian comprehension of the trial design. Against this background, the paper develops a non-static conceptual lens for understanding PADs. It shows that ADs are epistemically open and reduce some of the knowledge-associated uncertainties inherent in clinical trials as well as fast-track the time to draw conclusions about the value of evaluated drugs/treatments. On this note, the authors argue that PADs are ethically justifiable given they have multiple layers of safety, exposing enrolled children to lesser potential risks, create social/scientific value generally and for paediatric populations in particular, specifically foster the flourishing of paediatric populations and can significantly improve paediatric trial efficiency when properly designed and implemented. However, because PADs are relatively new and their regulatory, ethical and logistical characteristics are yet to be clarified in some jurisdictions, the cooperation of various public and private stakeholders is required to ensure that the interests of children, their caregivers and parents/guardians are best served while exposing paediatric research subjects to the most minimal of risks when they are enrolled in paediatric trials that use ADs. Data sharing not applicable as no datasets generated and/or analysed for this study. Not applicable. (shrink)

Current UK guidelines regarding clinical research on children permit research that is non-therapeutic from the perspective of that particular child. The guidelines permit research interventions that cause temporary pain, bruises or scars. It is argued here that such research conflicts with the Declaration of Helsinki according to which the interests of the research subject outweigh all other interests. Given this, in the context of clinical research, who is best placed to protect the child from this kind of exploitation? Is it (...) the medical researcher, the child’s parents or the nurse advocate? This article describes the problem, possible responses to it, and closes with a consideration of, and rejection of, a defence of current guidelines that claims moral parity between clinical research and clinical education. (shrink)

The future health of children depends on clinical research which is an important part of medical progress. The principles of the child’s best interests standards and how it is applied in the context of research are explored. This review will show that there is a need for research involving children but there are gaps in the current legal and ethical framework which are not readily applicable to non-therapeutic research involving children. There are significant challenges in trying to achieve a balance (...) between what is socially good and the obligation to protect children who participate in research. (shrink)

In order for children to receive the best possible medical treatment, it is essential that research is conducted to discover safe and effective interventions and dosages. This article focuses on the legal and ethical implications of recruiting into health-care research minors who are not competent to consent. It considers the role played by best interests in obtaining valid parental consent for the participation of children in research, both at common law and under the Regulations that govern clinical trials of medicinal (...) products. In doing so it questions the legality of parental consent to children's involvement in research, and identifies some inconsistencies in parental understandings of best interests in relation to medical research and treatment. (shrink)