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Clinical trials: the viewpoint of children with a chronic illness compared with healthy children
J Cherrill1, H Hudson, C Cocking
1Academic Division of Child Health, The University of Nottingham, Derby, UK.
Insights
Children with chronic illnesses better understand pediatric clinical trial concepts like dosing and placebo. They more strongly support children
Area of Science:
- Pediatric clinical trials
- Child health research
- Bioethics in medicine
Background:
- Understanding children's perspectives is crucial for ethical and effective pediatric clinical trials.
- Previous research has not fully explored the nuanced views of children, particularly those with chronic conditions, regarding their participation in medical research.
- Assessing children's comprehension of trial elements like dosing and placebo is vital for informed consent and participation.
Purpose of the Study:
- To investigate and compare the understanding and attitudes towards pediatric clinical trials among healthy children and those with chronic illnesses.
- To assess children's comprehension of key trial concepts, including medication dosing and placebo use.
- To evaluate children's willingness to participate in clinical trials and their ability to discern appropriate research contexts.
Main Methods:
- A questionnaire-based survey was administered to over 200 children aged 11-16 years.
- Participants included both healthy children and children attending pediatric medical clinics for chronic illnesses.
- The survey assessed understanding of trial concepts, willingness to participate, and ethical considerations in pediatric drug studies.
Main Results:
- Children with chronic illnesses demonstrated a superior understanding of medication dosing (40% vs. 23%) and placebo (34% vs. 20%) compared to healthy children.
- A higher proportion of children with chronic illnesses supported children's involvement in clinical trials (51% vs. 37%).
- Both groups showed good discernment regarding the appropriateness of studying medicines in children for conditions lacking treatment (86-89%), but less so for 'me-too' drugs (34-40%). A significant percentage (57-63%) expressed willingness to volunteer for cancer drug trials.
Conclusions:
- Children with chronic illnesses possess a more developed understanding of pediatric clinical trial parameters.
- Enhanced support for pediatric clinical trial participation exists among children with chronic conditions.
- There is a need to increase opportunities for young people to participate in decision-making processes for pediatric medicine research, especially concerning ethical considerations and appropriate trial design.
Abstract:
The views of over 200 children (11-16 years old, who were either healthy or attending paediatric medical clinics with a chronic illness) on issues relating to paediatric clinical trials were determined by a questionnaire. Children with a chronic illness had a better understanding of the concept of dosing of medicines (40% vs 23%) and placebo (34% vs 20%). They were more likely to support children's involvement in clinical trials (51% vs 37%). The altruistic nature of children in both groups was similar. It was of concern, however, that 57-63% children would participate as healthy volunteers in a cancer drug trial. Both groups were able to differentiate between the different types of illnesses where it is appropriate to study medicines in children (86-89% for illness where there is no treatment; 34-40% for 'me-too' drugs). Young people should be given more opportunities to be involved in decision-making regarding clinical trials of medicines.
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