Paediatric and adolescent obesity trials are now an established part of drug development, but major evidence gaps remain when translating findings across age groups. Regulatory architecture, including FDA draft guidance and ICH E11(R1), does not resolve how trial findings should be interpreted in a growing child. SCALE Teens and STEP TEENS demonstrate that GLP-1 receptor agonists improve BMI-based outcomes in adolescents, but evidence in children aged 6 to 11 remains sparse. Questions also remain around endpoint selection, body composition interpretation under active bone accrual and puberty, biomarker qualification, family-level attribution and participant retention.
This webinar explores these challenges through a graded evidence framework for obesity trials, helping sponsors distinguish established approaches from limited evidence and unresolved questions when designing global paediatric programmes. The featured panelists will discuss practical considerations across trial design, patient experience, biomarker strategy and multi-region regulatory planning.
The session will examine trial design and regulatory strategy for paediatric cohorts divided by age band, alongside validated, age-appropriate patient-reported outcome (PRO) instruments, cross-cultural adaptation and engagement approaches intended to address discontinuation risk in adolescent pharmacotherapy trials. It will also explore paediatric biomarkers and bioanalytical strategies, including how exploratory markers of metabolic dysfunction may be positioned for eventual regulatory acceptance without overstating the available evidence.
Rather than presenting a settled template, the session works from a graded framework: what is supported well enough to design, what rests only on limited teaching cases and what remains genuinely open, giving sponsors a practical, evidence-based framework for developing global paediatric obesity programmes.
Register for this webinar to learn how evidence-based endpoint, biomarker, retention and regulatory strategies can strengthen obesity trials in paediatric populations.
Who Should Attend
This webinar will appeal to:
Chief Executive Officers
Chief Medical Officers
Chief Scientific Officers
Medical Directors
VP/SVP Heads of Clinical Development
VPs of Clinical Operations
Heads of Regulatory Affairs
Heads of Biostatistics
Heads of Biomarker/Translational Science
Heads of Patient-Reported Outcomes/COA Strategy
What You Will Learn
Attendees will gain insight into:
How to apply a graded evidence framework to distinguish established protocol decisions from limited evidence and unresolved questions in paediatric obesity trials
How to evaluate BMI SDS, percentage BMIp95 and percentage change in BMI while interpreting DXA body composition in the context of bone accrual and puberty
How to assess exploratory biomarkers of metabolic dysfunction and determine their readiness for regulatory use
How family-level measures, age-appropriate PRO instruments, cross-cultural validation and engagement approaches can support retention and reduce visit burden
How to design a paediatric obesity programme that addresses FDA, EMA and NMPA requirements across multiple regions
Register free on Xtalks:
https://xtalks.com/webinars/improve-paediatric-obesity-trials-with-evidence-based-design/
