A constructive critique of the draft ICH E9 Addendum

Daniel O. Scharfstein

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


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)
Pages (from-to)375-380
Number of pages6
JournalClinical Trials
Issue number4
StatePublished - Aug 1 2019


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

ASJC Scopus subject areas

  • Pharmacology


Dive into the research topics of 'A constructive critique of the draft ICH E9 Addendum'. Together they form a unique fingerprint.

Cite this