EASO is pleased to report the publication of a new paper by an international group of colleagues working in childhood obesity. This cross - society group was convened at TOS2022 in San Diego by Prof Aaron Kelly and at ECO2023 in Dublin by EASO President - elect Dr Jennifer Baker and Dr Jen Christian Holm, with the aim of developing a consensus on considerations for the design and conduct of pediatric obesity pharmacotherapy clinical trials.
I was delighted to speak with Dr Jennifer Baker about the proceedings of the expert roundtable meetings, which can be accessed here: http://doi.org/10.1111/ijpo.13161
Congratulations on the new publication, Jennifer! Given the different approaches to pediatric obesity management in the US, Canada and European countries, what were the main challenges in reaching consensus among the diverse group of stakeholders regarding the primary and secondary endpoints to measure in pediatric obesity pharmacotherapy trials?
– Our biggest challenge was to find an endpoint that accurately reflects obesity severity and pathology, that indicates other health outcomes and quality of life, and importantly that is non-burdensome and easy to understand by patients and families, researchers and health care professionals.
I’m sure our readers are interested in understanding why the group decided to move away from using BMI z-score as the main outcome, and what other ways to measure success were considered for these trials?
– In the international setting, there are critical differences in how obesity, and especially severe obesity, are classified in children and adolescents in references. As a result, there are differences in what BMI zscores mean in terms of BMI change which complicates the interpretation of treatment. An ideal endpoint is one that accurately quantifies adiposity amount and distribution, but these are not readily available or validated. Until then, we strongly recommend to use other BMI metrics such as percent of the 95th percentile or percent of the median percentile as a main outcome. Importantly, we also recommend that multiple BMI metrics are reported on as to facilitate comparisons across studies.
The new paper talks about ethical concerns with long follow-up periods after stopping the medication, due to the risk of kids regaining weight. How did the team balance these ethical concerns with the need to understand the long-term effects of the medication?
– We suggest ending long follow-up phases because it may limit participant access to potentially effective treatments. We balance this by proposing the use of open-label extension phases so data on effectiveness and tolerability can be collected in a balance with the health of trial participants.