Pediatric Obesity:
Designing Better Studies Where Evidence is Limited
About this webinar
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 Regulatory architecture, including FDA draft guidance and ICH E11(R1), does not resolve how trial findings should be interpreted in a growing child.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
- 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
- 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
Featured Speakers
Graham C Ellis, MD
Dr. Graham C Ellis is a Specialist Physician and Clinical Vice President at Signant Health, bringing more than 25 years of experience in diabetes, endocrinology, metabolic disease and clinical research. He earned his Medical Degree from the University of Stellenbosch, South Africa, graduating cum laude and went on to found and lead HCTC, a prominent clinical research center, before joining PPD (Thermo Fisher Scientific) as Executive Director of Medical Science and Strategy.
Throughout his career, Dr. Ellis has served as Principal Investigator on more than 150 international Phase II-IV clinical trials, with extensive experience in type 2 diabetes, obesity, metabolic disease and diabetic complications. He is a founding member of the Centre for Diabetes and Endocrinology (CDE), a member of SEMDSA and serves on the Scientific Advisory Board of the Faculty of Science at Stellenbosch University. He is a peer reviewer for Diabetes, Obesity and Metabolism and has published in peer-reviewed international journals.
Justin Devine
Justin is a Medical Doctor, Immunologist and Clinical Pharmacologist and a Co-Founder of Synexa Life Sciences. Justin’s primary focus is to support groups involved in the ever-increasing complexity of new drug development to effectively navigate the dynamic biology landscape generated by the interplay of human disease pathophysiology and therapeutic intervention. Justin and his team seek to synthesize coherent biomarker and bioanalytical strategy with clinical development objectives to help groups make the best possible decision about the progression path of a new drug.
Shipra Patel
Shipra is a board-certified Pediatrician and Pediatric Endocrinologist. As a Medical Director at Parexel, she has gained extensive experience through medical monitoring for several Phase III type 2 diabetes trials, as well as a Phase II type 1 diabetes trial and a Phase IV type 2 diabetes trial. Her responsibilities have included providing therapeutic area and protocol training for team members, communicating with sites and sponsors and performing medical safety data review, safety processing and review of adjudication cases. In addition, she served as the Global Medical Monitor for a sarcopenia clinical drug trial in elderly patients and has gained experience in gastroenterology, nutritional and neonatology clinical drug trials.
Partner for this event
Signant Health
The speed, quality, and integrity of endpoint evidence is everything in being able to efficiently advance an experimental therapy forward. Signant is the evidence generation company that helps you digitally enable trials. No matter how or where you run your trials.
We make the patient journey more natural and intuitive, and the data journey more direct and objective. With the Signant SmartSignals ecosystem, Signant delivers proof at the speed of life, simplifying and streamlining data generation and reducing the reliance on paper-based evidence gathering and management.
We offer vision at a time of change as well as reliability and dependability where it matters most. When the world is counting on you, count on Signant.