Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children

Ian P. Sinha, Douglas G. Altman, Michael W Beresford, Maarten Boers, Mike Clarke, Jonathan Craig, Ornella Della Casa-Alberighi, Ricardo M. Fernandes, Lisa Hartling, Bradley C. Johnston, Andrew Lux, Amy Plint, Peter Tugwell, Mark Turner, Johanna H van der Lee, Martin Offringa, Paula R Williamson, Rosalind L. Smyth

Research output: Contribution to journalArticlepeer-review

53 Citations (Scopus)

Abstract

People making choices in health care should use the findings of clinical trials (ideally, incorporated in systematic reviews) to inform their decisions. If these findings are to be useful and reliable, researchers must select appropriate outcomes, measure them in a scientifically robust manner, and report results thoroughly. There are difficulties, however, relating to the selection and measurement of outcomes in clinical trials, and special considerations are needed when these studies are conducted in children.

This article provides guidance for researchers working on clinical trials in children. Although this article is focused on trials of effectiveness, which are similar to therapeutic confirmatory trials, certain sections may also relate to efficacy trials, pharmacokinetic trials, therapeutic exploratory trials, and trials conducted earlier in drug development.
Original languageEnglish
Pages (from-to)S146-S152
Number of pages7
JournalPediatrics
Volume129
Issue numberSUPPL. 3
DOIs
Publication statusPublished - Jun 2012

Bibliographical note

This is the fifth in a series of standard articles resulting from an ongoing process in which a group of invited experts called a Standard Development Group from StaR Child Health assembles and exchanges information about methods for pediatric trial design, conduct, and reporting. More detailed information about this topic can be found in the introductory article of this supplement or at the StaR Child Health Web site (www.starchildhealth.org).

Keywords

  • health care
  • decision making
  • clinical trials
  • children
  • Pediatrics
  • Outcome measures
  • StaR child health
  • Outcome sets
  • Selective reporting

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