The Science of Pediatric & Adolescent Obesity Trials
Evidence for a new Generation
Pediatric and adolescent obesity trials raise a distinct scientific challenge: proving safety, benefit, and durability in patients who are still developing. This page introduces the eight-part series that addresses it, and the companion eBook that brings it all together.
The series
Across eight chapters, Signant Health's clinical scientists and regulatory specialists work through the science behind paediatric and adolescent obesity trials, from epidemiology and endpoint design to consent, retention, and regulatory strategy. Read them in order below, or start with the chapter closest to your work.
Eight chapters,
one challenge
Each chapter stands on its own.
Together, they cover what it takes to study a growing child well.
01
02
Beyond BMI
Evolving primary endpoints and objective activity measurement in pediatric obesity trials
By Lauren Crooks, Director Clinical, Signant Health; Sylvain Zorman, Director, DHT Solutions Strategy, Ametris; and Dr. Graham C Ellis, MD, Clinical Vice President, Signant Health
03
The Mental Health Imperative
Why suicidality monitoring and eating-disorder surveillance are non-negotiable in padiatric GLP-1 trials
By Marcela Roy, Executive Director Clinical, Signant Health; and Joan Busner, Clinical Vice President, Signant Health
04
Assent, Privacy, and Family Considerations
The ethical infrastructure of adolescent obesity trials
By Viani Figueroa Vazquez, PhD, Associate Director, Science & Medicine, Signant Health; and Joan Busner, PhD, Clinical Vice President, Signant Health
05
Retaining Adolescents in Long-Duration Trials
Evidence-based strategies for a 52–72 week challenge
By Lauren Crooks, Director Clinical, Signant Health; Marcela Roy, Executive Director Clinical, Signant Health; and Elias Ketiar, Clinical Vice President, Signant Health
06
PRO Instrument Selection in Pediatric Obesity Trials
From PedsQL to IWQOL-Kids: what sponsors need to know
By Jeanine du Plessis, Associate Director, Clinical, Signant Health; Bill Byrom, VP Product Intelligence and Positioning, Signant Health; and Joan Busner, Clinical Vice President, Signant Health
07
The Regulatory Architecture of Paediatric AOM Trials
PREA, PIPs, and the FDA's January 2025 obesity guidance
By Viani Figueroa Vazquez, PhD, Associate Director, Science & Medicine, Signant Health; Dr. Graham C Ellis, MD, Clinical Vice President, Signant Health; and Joan Busner, Clinical Vice President, Signant Health
08
Monogenic and Syndromic Obesity in Children
A distinct trial design challenge
By Graham C Ellis, MD, Clinical Vice President, Signant Health; and Elias Ketiar, Clinical Vice President, Signant Health
Read the complete
guide
Download the eBook version of Evidence for a New Generation: all eight chapters and full references, in one file.
