[The designs of exploratory biomarker study].

Masahiko Gosho, Kengo Nagashima, Yasunori Sato

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Pages (from-to)874-879
Number of pages6
JournalNihon rinsho. Japanese journal of clinical medicine
Issue number5
Publication statusPublished - 2012 May
Externally publishedYes

ASJC Scopus subject areas

  • General Medicine


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