Clinical trials in oncology
著者
書誌事項
Clinical trials in oncology
(Interdisciplinary statistics)
Chapman & Hall/CRC, c2003
2nd ed
- : alk. paper
大学図書館所蔵 全5件
  青森
  岩手
  宮城
  秋田
  山形
  福島
  茨城
  栃木
  群馬
  埼玉
  千葉
  東京
  神奈川
  新潟
  富山
  石川
  福井
  山梨
  長野
  岐阜
  静岡
  愛知
  三重
  滋賀
  京都
  大阪
  兵庫
  奈良
  和歌山
  鳥取
  島根
  岡山
  広島
  山口
  徳島
  香川
  愛媛
  高知
  福岡
  佐賀
  長崎
  熊本
  大分
  宮崎
  鹿児島
  沖縄
  韓国
  中国
  タイ
  イギリス
  ドイツ
  スイス
  フランス
  ベルギー
  オランダ
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  ノルウェー
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注記
Bibliography: p. [237]-252
Index: p. [253]-265
内容説明・目次
内容説明
Studies that are unimpeachably thorough, non-political, unbiased, and properly designed... These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present.
The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background.
Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.
目次
INTRODUCTION
A Brief History of Clinical Trials
The Southwest Oncology Group
Example Trials
The Reason for the Book
STATISTICAL CONCEPTS
Introduction
The Phase II Trial-Estimation
The Phase III Trial-Hypothesis Testing
The Proportional Hazards Model
Sample Size Calculations
Concluding Remarks
THE DESIGN OF CLINICAL TRIALS
Introduction
Endpoints
Phase I Trials
Phase II Trials
Phase III Trials
Conclusion
MULTI-ARM TRIALS
Introduction
Types of Multi-Arm Trials
Significance Level
Power
Interaction
Other Model Assumptions
To Screen or Not to Screen
Timing of Randomization
Conclusion
INTERIM ANALYSIS AND DATA MONITORING COMMITTEES
Planned Interim Analysis
Data Monitoring Committees: Rationale and Responsibilities
Monitoring Committees: Composition
Examples
Concluding Remarks
DATA MANAGEMENT AND QUALITY CONTROL
Introduction: Why Worry?
Protocol Development
Data Collection
Protocol Management and Evaluation
Quality Assurance Audits
Training
Data Base Management
Conclusion
Appendix: Examples
REPORTING OF RESULTS
Timing of Report
Required Information
Analyses
Conclusion
PITFALLS
Introduction
Historical Controls
Competing Risks
Outcome by Outcome Analyses
Subset Analyses
Surrogate Endpoints
EXPLORATORY ANALYSES
Introduction
Some Background and Notation
Identification of Prognostic Factors
Forming Prognostic Groups
Analysis of Microarray Data
Meta-Analysis
Concluding Remarks
SUMMARY AND CONCLUSIONS
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