Information-based group sequential design for post-market safety monitoring of medical products using real world data

Zhiwei Zhang, Carrie Nielson, Ching Yi Chuo, Zhishen Ye

Research output: Contribution to journalArticlepeer-review

Original languageEnglish
Pages (from-to)778-790
Number of pages13
JournalPharmaceutical Statistics
Volume23
Issue number5
DOIs
StatePublished - Sep 1 2024
Externally publishedYes

ASJC Scopus Subject Areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

Keywords

  • alpha spending function
  • information fraction
  • interim analysis
  • pharmaco-vigilance
  • post-market surveillance
  • safety signal refinement

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