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Anthropometric Exclusions in Pediatric Clinical Trials: Implications for Medication Dosing in Malnourished Children

Susan M Abdel-Rahman1, Sherbet Samuels1, Janie Cole2

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Journal of Clinical Pharmacology
|October 13, 2025
PubMed

Insights

Pediatric clinical trials frequently exclude malnourished children, particularly those who are undernourished. This exclusion limits data for vulnerable populations and may not reflect real-world patient demographics.

Area of Science:

  • Pediatric Clinical Trials
  • Drug Development
  • Nutritional Science

Background:

  • Malnutrition is prevalent in children with complex medical conditions, impacting drug efficacy.
  • Current FDA-approved drug labels seldom account for malnutrition in pediatric dosing.
  • Exclusionary criteria in clinical trials can limit the generalizability of findings.

Purpose of the Study:

  • To investigate the frequency and nature of malnutrition-related exclusion criteria in pediatric clinical trials.
  • To determine if specific study phases, intervention types, or indications are associated with higher exclusion rates.
  • To assess the impact of these criteria on trial populations and their representativeness of real-world patients.

Main Methods:

  • Systematic review of industry-sponsored, pediatric, phase I-III clinical trial protocols from ClinicalTrials.Gov.
  • Analysis of inclusion and exclusion (I/E) criteria for anthropometric and clinical indicators of malnutrition.
  • Characterization of I/E criteria by study phase, intervention type, and treatment indication.

Main Results:

  • Of 1759 reviewed protocols, 616 (35%) contained 777 malnutrition-related I/E criteria.
  • 71% of protocols excluded undernourished children, 9% excluded overnourished children, and 20% excluded both.
  • Exclusions were most common in respiratory, mental/behavioral, and obstetric/perinatal indications; least common in dermatologic and oncologic studies.
  • Non-specific criteria likely lead to an underestimation of malnutrition-based exclusions.

Conclusions:

  • Pediatric clinical trials disproportionately exclude undernourished children, despite growing attention to obesity.
  • These exclusions create trial populations that may not mirror the clinical reality of patients with complex conditions.
  • Consideration should be given to modifying I/E criteria in studies involving conditions with high malnutrition rates to improve trial relevance.

Keywords:
clinical trialsobesitypediatricpharmacologyunderweight

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