論文

査読有り
2012年4月

Statistical Issues and Recommendations for Noninferiority Trials in Oncology: A Systematic Review

CLINICAL CANCER RESEARCH
  • Shiro Tanaka
  • ,
  • Yousuke Kinjo
  • ,
  • Yoshiki Kataoka
  • ,
  • Kenichi Yoshimura
  • ,
  • Satoshi Teramukai

18
7
開始ページ
1837
終了ページ
1847
記述言語
英語
掲載種別
DOI
10.1158/1078-0432.CCR-11-1653
出版者・発行元
AMER ASSOC CANCER RESEARCH

To provide an overview of noninferiority trials in oncology with a special emphasis on methodologic issues, we conducted a systematic review of randomized trials assessing noninferiority of antineoplastic treatments. We identified 72 articles, of which 65 were randomized phase III trials with a single control arm, 3 were factorial phase III trials, and 4 were randomized phase II trials. Forty-six were trials in lung, colorectal, or breast cancer. The quality of reporting was improved chronologically (P < 0.01); the major deficiencies were claims of noninferiority when the results did not meet statistical criteria for noninferiority (7 articles) or when the noninferiority margin was not prespecified (5 articles). Four trials (6%) presented plans for switching from superiority to noninferiority. The analysis populations were intent to treat (ITT) in 52, perprotocol set (PPS) in 6, and both ITT and PPS in 11 trials. Noninferiority margins were set in 68 trials (94%); 1 trial used both of the conventional and effect retention methods, 17 trials used the conventional method, 5 trials used the effect retention method, and in 45 trials, the method was not specified. Some trials used margins that possibly were larger than the assured effects of the active controls. No trials explicitly took into consideration uncertainty in historical data. Two trials (3%) specified 2 values of margins. Our findings highlight critical deficiencies in design and reporting of noninferiority trials. Seven practical recommendations are presented. Clin Cancer Res; 18(7); 1837-47. (C) 2012 AACR.

リンク情報
DOI
https://doi.org/10.1158/1078-0432.CCR-11-1653
J-GLOBAL
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201302287130827456
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/22317762
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000302549900005&DestApp=WOS_CPL
ID情報
  • DOI : 10.1158/1078-0432.CCR-11-1653
  • ISSN : 1078-0432
  • eISSN : 1557-3265
  • J-Global ID : 201302287130827456
  • PubMed ID : 22317762
  • Web of Science ID : WOS:000302549900005

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