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- catalog abstract "This book 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. This book 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.".
- catalog contributor b13212909.
- catalog contributor b13212910.
- catalog contributor b13212911.
- catalog created "c2003.".
- catalog date "2003".
- catalog date "c2003.".
- catalog dateCopyrighted "c2003.".
- catalog description "A brief history of clinical trials -- The Southwest Oncology Group -- Example trials -- Statistical Concepts -- The Phase II trial--estimation -- The Phase III trial -- hypothesis testing -- Response as the outcome -- Survival as the outcome -- The proportional hazards model -- Sample size calculations -- The Design of Clinical Trials -- Eligibility, treatments, endpoints -- Differences to be detected or precision of estimates -- Method of treatment assignment -- Assumptions for sample size calculation -- Endpoints -- Phase I trials -- Traditional designs -- Newer Phase I designs -- Phase I/II designs -- Considerations for biologic agents -- Phase II trials -- The Standard Southwest Oncology Group Phase II design -- Randomized Phase II designs -- Other Phase II designs -- Phase III trials -- Randomization -- Two-arm trials -- Equivalence or noninferiority trials -- Multi-Arm Trials -- Types of multi-arm trials -- Significance level -- Power -- Interaction -- Other model assumptions -- To screen or not to screen -- Timing of randomization -- Interim Analysis and Data Monitoring Committees -- Planned interim analyses -- Data monitoring committees: Rationale and responsibilities -- Monitoring committees: Composition -- Stopping early for positive results -- Stopping early for negative results -- Stopping an equivalence trial early for positive results -- Stopping based on toxicity and lack of compliance -- Emergency stopping based on unexpected toxic deaths -- Data Management and Quality Control -- Introduction: Why worry?".
- catalog description "Includes bibliographical references (p. [237]-252) and index.".
- catalog description "This book 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. This book 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.".
- catalog extent "xi, 265 p. :".
- catalog identifier "1584883022 (alk. paper)".
- catalog isPartOf "Interdisciplinary statistics series".
- catalog isPartOf "Interdisciplinary statistics.".
- catalog issued "2003".
- catalog issued "c2003.".
- catalog language "eng".
- catalog publisher "Boca Raton : Chapman & Hall,".
- catalog subject "616.99/4/00727 21".
- catalog subject "Cancer Research Statistical methods.".
- catalog subject "Clinical Trials as Topic Statistics.".
- catalog subject "Clinical Trials as Topic standards Statistics.".
- catalog subject "Clinical Trials as Topic standards.".
- catalog subject "Clinical Trials as Topic".
- catalog subject "Clinical trials.".
- catalog subject "Data Interpretation, Statistical.".
- catalog subject "Neoplasms therapy Statistics.".
- catalog subject "Neoplasms therapy.".
- catalog subject "QZ 16 G798c 2002".
- catalog subject "RC267 .G744 2003".
- catalog tableOfContents "A brief history of clinical trials -- The Southwest Oncology Group -- Example trials -- Statistical Concepts -- The Phase II trial--estimation -- The Phase III trial -- hypothesis testing -- Response as the outcome -- Survival as the outcome -- The proportional hazards model -- Sample size calculations -- The Design of Clinical Trials -- Eligibility, treatments, endpoints -- Differences to be detected or precision of estimates -- Method of treatment assignment -- Assumptions for sample size calculation -- Endpoints -- Phase I trials -- Traditional designs -- Newer Phase I designs -- Phase I/II designs -- Considerations for biologic agents -- Phase II trials -- The Standard Southwest Oncology Group Phase II design -- Randomized Phase II designs -- Other Phase II designs -- Phase III trials -- Randomization -- Two-arm trials -- Equivalence or noninferiority trials -- Multi-Arm Trials -- Types of multi-arm trials -- Significance level -- Power -- Interaction -- Other model assumptions -- To screen or not to screen -- Timing of randomization -- Interim Analysis and Data Monitoring Committees -- Planned interim analyses -- Data monitoring committees: Rationale and responsibilities -- Monitoring committees: Composition -- Stopping early for positive results -- Stopping early for negative results -- Stopping an equivalence trial early for positive results -- Stopping based on toxicity and lack of compliance -- Emergency stopping based on unexpected toxic deaths -- Data Management and Quality Control -- Introduction: Why worry?".
- catalog title "Clinical trials in oncology / Stephanie Green, Jacqueline Benedetti, John Crowley.".
- catalog type "Statistics.".
- catalog type "text".