An Introduction to the Ethical Design, Conduct, and Analysis of Pediatric Clinical Trials

Myron Yaster, Jeffrey Galinkin, Mark S. Schreiner

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Few drugs administered to infants and children have been studied for efficacy and safety in these patients. The randomized, blinded, placebo-controlled clinical trial is the indispensable "gold standard" for determining the efficacy of therapeutics. Trials are time consuming, maddeningly difficult and often very expensive to perform, and frustrating from inception to execution to completion. However, the failure to properly perform a trial results in perpetual uncertainty and possibly patient harm. Performing a proper trial takes time to develop a protocol, create and test the data collection forms, obtain support and funding, and establish the structure for data intake and analysis. Once completed, the results of the trial must be published and made available to the public and regulatory agencies. Finally, above all else, all aspects of trial conduct must adhere to accepted ethical standards.

Original languageEnglish (US)
Title of host publicationGregory's Pediatric Anesthesia
Subtitle of host publicationFifth Edition
PublisherWiley-Blackwell
Pages40-59
Number of pages20
ISBN (Print)1444333461, 9781444333466
DOIs
StatePublished - Dec 9 2011

Keywords

  • Acceptable risk
  • Children
  • Clinical trials
  • Committee on human research
  • Controlled trials
  • Ethics
  • Masking
  • Outcome measures
  • Randomization
  • Randomized
  • Recruitment
  • Research

ASJC Scopus subject areas

  • Medicine(all)

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