A constructive critique of the draft ICH E9 Addendum

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Abstract

In this article, I review the key elements of the proposed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E9 Addendum, present a constructive critique, and provide recommendations of how it can be improved. To highlight ideas, I present a case study involving a confirmatory trial for a chronic pain medication.

Original languageEnglish (US)
JournalClinical Trials
DOIs
StatePublished - Jan 1 2019

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Keywords

  • Estimand
  • intention-to-treat
  • pain
  • sensitivity analysis
  • treatment strategy

ASJC Scopus subject areas

  • Pharmacology

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