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research / researchbiomarker statistics and validation

Lisa M. McShane

丽莎·麦克肖恩

PhD

🏢National Cancer Institute, NIH(美国国家癌症研究所)🌐USA

Chief, Biometric Research Program生物统计研究项目负责人

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h-index
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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Lisa M. McShane is a leading biostatistician specializing in the design and analysis of biomarker studies in oncology. She is co-developer of the REMARK reporting guidelines, the international standard for transparent reporting of tumor marker prognostic studies, adopted by over 100 journals. Her methodological work addresses critical issues of overfitting, selection bias, and multiple testing in high-dimensional biomarker discovery. McShane has made seminal contributions to the statistical foundations of companion diagnostic development and adaptive biomarker-enriched trial designs.

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🧪Research Fields 研究领域

biomarker statistics生物标志物统计
REMARK reporting guidelinesREMARK报告指南
clinical trial design临床试验设计
omics biomarkers组学生物标志物
predictive modeling预测建模

🎓Key Contributions 主要贡献

REMARK Reporting Standards

Co-authored the REMARK guidelines for reporting tumor marker studies, establishing transparent reporting standards now required by major oncology journals worldwide.

Biomarker Statistical Methods

Developed statistical frameworks addressing overfitting and validation of high-dimensional genomic biomarkers, improving reproducibility in precision oncology.

Representative Works 代表性著作

[1]

Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)

Journal of the National Cancer Institute (2005)

Defining guidelines for transparent reporting of tumor marker studies.

[2]

Statistical Design of Translational Cancer Biomarker Studies

Clinical Cancer Research (2009)

Statistical framework for biomarker clinical validation design.

🏆Awards & Recognition 奖项与荣誉

🏆NCI Director Award
🏆ASA Section on Statistics in Epidemiology Distinguished Achievement Award

📄Data Sources 数据来源

Institution

Last updated: 2026-01-15 | All information from publicly available academic sources

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