[The designs of exploratory biomarker study].

Masahiko Gosho, Kengo Nagashima, Yasunori Sato

研究成果: Review article査読

抄録

With the progress of molecular biology and other disciplines, biomarkers are becoming increasingly important in both drug discovery and development. Several critical issues, including scientific rationale, study design, marker assessment, cost and feasibility should be carefully considered in the validation of biomarkers through clinical research. Here, we highlight several important aspects related to the design for clinical researches which incorporate biomarkers. First, we define the term "biomarker" and illustrate the difference between prognostic and predictive markers. Second, in exploratory clinical studies, we focus on issues related to study design for screening and evaluating biomarkers. Finally, we review the design of confirmatory clinical trials for new treatments and companion biomarker diagnostic tests.

本文言語English
ページ(範囲)874-879
ページ数6
ジャーナルNihon rinsho. Japanese journal of clinical medicine
70
5
出版ステータスPublished - 2012 5
外部発表はい

ASJC Scopus subject areas

  • 医学(全般)

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