Anthropometric Exclusions in Pediatric Clinical Trials: Implications for Medication Dosing in Malnourished Children.
Malnutrition occurs at higher rates in children with complex medical conditions and can independently influence drug disposition and action. Yet FDA‐approved product labels rarely address dosing in malnutrition. This study explores the extent to which malnourished children are expressly excluded fro...
| Publicado en: | Journal of Clinical Pharmacology Vol. 66; no. 3; pp. 1 - 8 |
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| Autores principales: | , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Mar2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=192476863&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 192476863 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00912700 5WH jtl: Journal of Clinical Pharmacology issn: 00912700 maglogo: Y pubinfo: dt: Mar2026 vid: 66 iid: 3 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 192476863 188593103 192476863 192476863 10.1002/jcph.70120 192476863 ppf: 1 ppct: 7 formats: tig: atl: Anthropometric Exclusions in Pediatric Clinical Trials: Implications for Medication Dosing in Malnourished Children. aug: au: Abdel‐Rahman, Susan M. Samuels, Sherbet Cole, Janie Burckart, Gilbert J. affil: Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring MD,, USA sug: subj: Malnutrition In Infancy and Childhood Clinical Trials Research Subject Recruitment Anthropometry Dosage Calculation Human Child Clinical Indicators Descriptive Statistics Overnutrition Undernutrition Pediatric Obesity Thinness Pharmacy and Pharmacology Chi Square Test Logistic Regression Data Analysis Software Child: 6-12 years ab: Malnutrition occurs at higher rates in children with complex medical conditions and can independently influence drug disposition and action. Yet FDA‐approved product labels rarely address dosing in malnutrition. This study explores the extent to which malnourished children are expressly excluded from clinical trials. Industry‐sponsored, pediatric, phase I‐III studies deposited in ClinicalTrials.Gov through December 2024 with a full study protocol were reviewed. Protocols were evaluated for inclusion and exclusion (I/E) criteria related to anthropometric and clinical indicators of malnutrition. I/E criteria were fully characterized along with the study phase, intervention type, and treatment indication. 9882 studies were identified, 1759 with an uploaded protocol. 616 studies (35%) contained 777 distinct I/E criteria related to malnutrition (1–6 per study). Across all protocols, 71% exclusively restricted participation of children with evidence of undernutrition, 9% with overnutrition, and 20% with both. There were no statistical differences observed based on intervention type, though differences by study phase were observed. Restrictions were seen most frequently for respiratory, mental/behavioral, obstetric/perinatal, and emergency use indications and least frequently for dermatologic, oncologic, and eyes, ears, nose, and throat disorders. Non‐specific I/E criteria suggest that these findings likely underestimate the extent of malnutrition‐based exclusions. Despite growing attention paid to obesity, pediatric clinical trials are far more likely to restrict the participation of undernourished children. Though unrealistic to relax malnutrition related I/E criteria for all studies, consideration should be given for conditions where high rates of malnutrition are expected to avoid trial populations that do not reflect clinical practice. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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