임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

임상시험에서 사용되는 기본통계개념에 관한 고찰

A Review of Fundamentals of Statistical Concepts in Clinical Trials

  • 최경미 (홍익대학교 과학기술대학 교양(수학)과) ;
  • 이종태 (가톨릭대학교 의과대학 약리학교실 및 서울성모병원 임상약리과) ;
  • 전상일 (가톨릭대학교 의과대학 약리학교실 및 서울성모병원 임상약리과) ;
  • 홍태곤 (가톨릭대학교 의과대학 약리학교실 및 서울성모병원 임상약리과) ;
  • 백정기 (가톨릭대학교 의과대학 약리학교실 및 서울성모병원 임상약리과) ;
  • 한승훈 (가톨릭대학교 의과대학 약리학교실 및 서울성모병원 임상약리과) ;
  • 임동석 (가톨릭대학교 의과대학 약리학교실 및 서울성모병원 임상약리과)
  • Choi, Kyungmee (Divison of Mathematics, College of Science and Technology, Hongik University at Sejong) ;
  • Lee, Jongtae (Department of Pharmacology, College of Medicine, the Catholic University of Korea and Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital) ;
  • Jeon, Sangil (Department of Pharmacology, College of Medicine, the Catholic University of Korea and Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital) ;
  • Hong, Taegon (Department of Pharmacology, College of Medicine, the Catholic University of Korea and Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital) ;
  • Paek, Jeongki (Department of Pharmacology, College of Medicine, the Catholic University of Korea and Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital) ;
  • Han, Seunghoon (Department of Pharmacology, College of Medicine, the Catholic University of Korea and Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital) ;
  • Yim, Dong-Seok (Department of Pharmacology, College of Medicine, the Catholic University of Korea and Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital)
  • 투고 : 2012.06.14
  • 심사 : 2012.11.06
  • 발행 : 2012.12.31
⟨ 이전 논문 다음 논문 ⟩

초록

Statistical analysts engaged in typical clinical trials often have to confront a tight schedule to finish massive statistical analyses specified in a Standard Operation Procedure (SOP). Thus, statisticians or not, most analysts would want to reuse or slightly modify existing programs. Since even a slight misapplication of statistical methods or techniques can easily drive a whole conclusion to a wrong direction, analysts should arm themselves with well organized statistical concepts in advance. This paper will review basic statistical concepts related to typical clinical trials. The number of variables and their measurement scales determine an appropriate method. Since most of the explanatory variables in clinical trials are designed beforehand, the main statistics we review for clinical trials include univariate data analysis, design of experiments, and categorical data analysis. Especially, if the response variable is binary or observations collected from a subject are correlated, the analysts should pay special attention to selecting an appropriate method. McNemar's test and multiple McNemar's test are respectively recommended for comparisons of proportions between correlated two samples or proportions among correlated multi-samples.

키워드

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