Handbook of Statistics in Clinical Oncology

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Handbook of Statistics in Clinical Oncology

Format:  Hardcover,

635 pages

Edition: Revised

Publisher: CRC Press

Publish Date: Mar 2012

ISBN-13: 9781439862001

ISBN-10: 1439862001

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Book Information

The following content was provided by the publisher.

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research.

Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts:

  • Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents.
  • Phase II trials Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs.
  • Phase III trials Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials.
  • Exploratory and high-dimensional data analyses All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added.

Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

Specifications

Editor:
Editor:
Publisher: CRC Press
Publish Date: Mar 2012
ISBN-13: 9781439862001
ISBN-10: 1439862001
Format: Hardcover
Number of Pages: 635
Shipping Weight (in pounds): 2.4
Product in Inches (L x W x H): 6.4 x 1.7 x 9.1
Walmart No.: 9781439862001

Chapter outline

Preface
Editors
Contributors
Phase I Trials
Choosing a Phase I Design
Dose-Finding Designs Based on the Continual Reassessment Method
Pharmacokinetics in Clinical Oncology: Statistical Issues
Statistics of Phase 0 Trials
CRM Trials for Assessing Toxicity and Efficacy
Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents
Phase II Trials
Overview of Phase II Clinical Trials
Designs Based on Toxicity and Response
Designs Using Time-to-Event Endpoints/Single-Arm versus Randomized Phase II Designs
Phase II Selection Designs
Phase II with Multiple Subgroups: Designs Incorporating Disease Subtype or Genetic Heterogeneity
Phase II/III Designs
Phase III Trials
Use of Covariates in Randomization and Analysis of Clinical Trials
Factorial Designs with Time-to-Event Endpoints
Early Stopping of Clinical Trials
Noninferiority Trials
Phase III Trials for Targeted Agents
Adaptive Trial Designs
Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit
Software for Design and Analysis of Clinical Trials
Cure-Rate Survival Models in Clinical Trials
Design and Analysis of Quality-of-Life Data,
Economic Analyses alongside Cancer Clinical Trials
Structural and Molecular Imaging in Cancer Therapy Clinical Trials
Exploratory and High-Dimensional Data Analyses
Prognostic Factor Studies
Predictive Modeling of Gene Expression Data
Explained Variation and Explained Randomness for Proportional Hazards Models
Prognostic Groups by Tree-Based Partitioning and Data Refinement Methods
Risk Calculators
Developing a Score Based upon Gene Expression Profiling and Validation
Analysis of DNA Microarrays
Methods for SNP Regression Analysis in Clinical Studies: Selection, Shrinkage, and Logic
Forensic Bioinformatics
Index

Book description

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research.

Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts:

  • Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents.
  • Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs.
  • Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials.
  • Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added.

Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

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