Review of “Points to Consider on Multiplicity Issues in Clinical Trials” and Issues to be Discussed

• Fujikoshi Shinji

  Eli Lilly Japan K.K. Medical Statistics

Bibliographic Information

Other Title

• Points to Consider on Multiplicity Issues in Clinical Trialsの内容紹介および問題提起
• Points to Consider on Multiplicity Issues in Clinical Trials ノ ナイヨウ ショウカイ オヨビ モンダイ テイキ

Abstract

“Points to Consider on Multiplicity Issues in Clinical Trials” published by CPMP of EMEA in September 2003 is reviewed and issues to be discussed are identified. First, the examples identified in the PtC as unnecessary cases of “adjusting the type I error level” are grouped into 3 patterns, and the situation and the characteristics of each pattern are explained. After reviewing each pattern, important points for conducting the confirmatory trial according to PtC are summarized. Issues to be discussed about the content and the concrete measures are also addressed.

Journal

• Japanese Journal of Biometrics

  Japanese Journal of Biometrics 27 (Special_Issue), S64-S72, 2006

  The Biometric Society of Japan

Keywords

• CPMP
• PtC on Multiplicity Issues in Clinical Trials
• Family-wise type I error in the strong sense
• adjusting the type I error level
• Confirmatory Hypothesis

Details

• CRID: 1390282679345189888
• NII Article ID: 10018357526
• NII Book ID: AA11591618
• DOI: 10.5691/jjb.27.s64
• ISSN: 21856494
• ISSN: 09184430
• NDL BIB ID: 8532481
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I8532481
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • CiNii Articles
• Abstract License Flag: Disallowed