Developments in the Design, Conduct, and Reporting of Child Health Trials.

To identify priority areas to improve the design, conduct, and reporting of pediatric clinical trials, the international expert network, Standards for Research (StaR) in Child Health, was assembled and published the first 6 Standards in Pediatrics in 2012. After a recent review summarizing the 247 p...

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Publicado en:Pediatrics Vol. 154; no. 1; pp. 1 - 14
Autores principales: Baba, Ami, Aregbesola, Alex, Caldwell, Patrina H. Y., Elliott, Sarah A., Elsman, Ellen B. M., Fernandes, Ricardo M., Hartling, Lisa, Heath, Anna, Kelly, Lauren E., Preston, Jennifer, Sammy, Adrian, Webbe, James, Williams, Katrina, Woolfall, Kerry, Klassen, Terry P., Offringa, Martin
Formato: review tables/charts Journal Article
Publicado: American Academy of Pediatrics Jul2024
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jul2024
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      pub: American Academy of Pediatrics
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        178262844
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        10.1542/peds.2024-065799
        178262844
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        atl: Developments in the Design, Conduct, and Reporting of Child Health Trials.
      aug:
        au:
          Baba, Ami
          Aregbesola, Alex
          Caldwell, Patrina H. Y.
          Elliott, Sarah A.
          Elsman, Ellen B. M.
          Fernandes, Ricardo M.
          Hartling, Lisa
          Heath, Anna
          Kelly, Lauren E.
          Preston, Jennifer
          Sammy, Adrian
          Webbe, James
          Williams, Katrina
          Woolfall, Kerry
          Klassen, Terry P.
          Offringa, Martin
        affil: Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
      sug:
        subj:
          Child Health
          Pediatrics Standards
          Study Design Standards
          Clinical Trials
          Research, Medical
          Implementation Science
          Outcome Assessment
          Age Factors
      ab: To identify priority areas to improve the design, conduct, and reporting of pediatric clinical trials, the international expert network, Standards for Research (StaR) in Child Health, was assembled and published the first 6 Standards in Pediatrics in 2012. After a recent review summarizing the 247 publications by StaR Child Health authors that highlight research practices that add value and reduce research "waste," the current review assesses the progress in key child health trial methods areas: consent and recruitment, containing risk of bias, roles of data monitoring committees, appropriate sample size calculations, outcome selection and measurement, and age groups for pediatric trials. Although meaningful change has occurred within the child health research ecosystem, measurable progress is still disappointingly slow. In this context, we identify and review emerging trends that will advance the agenda of increased clinical usefulness of pediatric trials, including patient and public engagement, Bayesian statistical approaches, adaptive designs, and platform trials. We explore how implementation science approaches could be applied to effect measurable improvements in the design, conducted, and reporting of child health research.
      pubtype: Academic Journal
      doctype:
        review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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