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Translational Medicine / 转化医学Clinical Trial Innovation

Richard Simon

理查德·西蒙

DSc

🏢National Cancer Institute (NCI) / Georgetown University(美国国家癌症研究所 / 乔治城大学)🌐USA

Chief Emeritus, Computational & Systems Biology Branch, NCI; Professor, Georgetown UniversityNCI计算与系统生物学部荣誉主任;乔治城大学教授

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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

Richard Simon, DSc is a foundational figure in biomarker-driven clinical trial design at the NCI. His statistical frameworks, including enrichment designs, adaptive signature designs, and master protocols, have become the methodological bedrock for precision oncology trials and companion diagnostic development worldwide.

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🧪Research Fields 研究领域

Biomarker Clinical Trial Design生物标志物临床试验设计
Enrichment Strategies富集策略
Master Protocols主协议
Adaptive Signature Design适应性特征设计
Precision Medicine Trial Methodology精准医学试验方法学

🎓Key Contributions 主要贡献

Biomarker Enrichment Strategies for Clinical Trials

Developed foundational statistical frameworks for biomarker enrichment strategies in clinical trials, including the all-comers, enrichment, and marker-stratified designs used across precision oncology globally.

Adaptive Signature Design and Master Protocols

Invented the adaptive signature design and contributed extensively to master protocol methodology, enabling biomarker discovery and validation within single efficient trial frameworks.

Representative Works 代表性著作

[1]

Using Genomics in Clinical Trial Design

Clinical Cancer Research (2008)

Landmark methodological paper establishing principles for incorporating genomic biomarkers into clinical trial design, widely cited across precision oncology.

[2]

Biomarker-Based Clinical Trial Designs for Precision Medicine

Nature Reviews Drug Discovery (2017)

Comprehensive review of biomarker trial design strategies including enrichment, adaptive signature, and master protocol approaches for precision oncology.

🏆Awards & Recognition 奖项与荣誉

🏆American Statistical Association Fellow
🏆NCI Director's Award for Outstanding Service
🏆Biometric Society Distinguished Paper Award
🏆FDA Commissioner's Special Citation

📄Data Sources 数据来源

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

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