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Role of Patients and Parents in Pediatric Drug Development
Vivian W L Tsang1, Leanne West2, Christine Woods3
11 Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Insights
Pediatric patients and families are crucial experts in healthcare, yet their input is often missing in pediatric clinical trials and drug development. This review highlights best practices for incorporating their voices to improve child health outcomes.
Area of Science:
- Pediatric Health Research
- Clinical Trial Methodology
- Patient Engagement
Background:
- Patient engagement is increasingly recognized as vital in healthcare, with patients viewed as experts in their own conditions.
- Historically, pediatric patients' and families' input has been undervalued in pediatric clinical trial design and outcome assessment.
- This gap is particularly concerning in pediatric drug development, leading to off-label prescribing and adverse events.
Purpose of the Study:
- To review current best practices for involving pediatric patients and families in drug development.
- To examine progress made by regulatory agencies in including children and youth in clinical trials.
- To highlight global advocacy efforts aimed at amplifying the voices of children and youth in pharmaceutical research.
Main Methods:
- International expert review of current best practices.
- Analysis of regulatory agency progress and legislative changes in North America and Europe.
- Examination of global patient advocacy and advisory group initiatives.
Main Results:
- Despite legislative advancements, systematic guidelines for incorporating pediatric patient input are lacking.
- Pediatric advocacy groups play a key role in advancing patient involvement.
- International experts convened to discuss and review progress.
Conclusions:
- Incorporating pediatric patient and family perspectives early in drug development is essential.
- Systematic methodologies and guidelines are needed to overcome barriers to practical application.
- Valuing the voice of children and youth is critical for future pediatric drug development and improved health outcomes.
Abstract:
Patient engagement in health care has been an emerging priority in the global effort and move toward the consideration of patients as experts of their own conditions. However, the input of pediatric patients and their families have not been consistently requested nor regarded as valuable when deriving protocols for, as well as assessing the outcomes of, pediatric clinical trials. Extending this mutual collaboration further upstream is important, especially in the area of pediatric drug development where the lack of formalized trials for children and adolescents result in the increased use of off-label prescribing and risk of adverse effects. While recent changes to European and North American legislation contributed to the inclusion of children and youth in pediatric drug development, the lack of systematic guidelines and methodologies in literature serve as barriers for practical application. When combined with the work of external pediatric advocacy and patient advisory groups, the hope is that pediatric patient voices can be brought forward for the future. This article brings together international experts to review current best practices, progress from regulatory agencies, as well as global advocacy efforts to involve patients and families in the pursuit of drug development processes that value the voice of children and youth.
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01:27Parenting Styles
Authoritarian Parenting
This style is strict and controlling, with little room for open dialogue. Authoritarian parents demand obedience and often enforce rules with minimal warmth. Children raised this way may lack social skills and initiative, usually comparing themselves to others unfavorably.
Authoritative...