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Material or Process Book or Chapter Title Author or Editor Publication dates

Handbook of Statistics in Clinical Oncology

Edited by: John Crowley , Antje Hoering

Print publication date:  March  2012
Online publication date:  March  2012

Print ISBN: 9781439862001
eBook ISBN: 9781439862018
Adobe ISBN:

10.1201/b11800
 Cite  Marc Record

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.

Table of contents

Chapter  1:  Choosing a Phase I Design Download PDF
Chapter  2:  Dose-Finding Designs Based on the Continual Reassessment Method Download PDF
Chapter  3:  Pharmacokinetics in Clinical Oncology Statistical Issues Download PDF
Chapter  4:  Statistics of Phase 0 Trials Download PDF
Chapter  5:  CRM Trials for Assessing Toxicity and Efficacy Download PDF
Chapter  6:  Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents Download PDF
Chapter  7:  Overview of Phase II Clinical Trials Download PDF
Chapter  8:  Designs Based on Toxicity and Response Download PDF
Chapter  9:  Designs Using Time-to-Event Endpoints/Single-Arm versus Randomized Phase II Designs Download PDF
Chapter  10:  Phase II Selection Download PDF
Chapter  11:  Phase II with Multiple Subgroups: Designs Incorporating Disease Subtype or Genetic Heterogeneity Download PDF
Chapter  12:  Phase II/III Designs Download PDF
Chapter  13:  Use of Covariates in Randomization and Analysis of Clinical Trials Download PDF
Chapter  14:  Factorial Designs with Time-to-Event Endpoints Download PDF
Chapter  15:  Early Stopping of Clinical Trials Download PDF
Chapter  16:  Noninferiority Trials Download PDF
Chapter  17:  Phase III Trials for Targeted Agents Download PDF
Chapter  18:  Adaptive Trial Designs Download PDF
Chapter  19:  Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit Download PDF
Chapter  20:  Software for Design and Analysis of Clinical Trials Download PDF
Chapter  21:  Cure-Rate Survival Models in Clinical Trials Download PDF
Chapter  22:  Design and Analysis of Quality-of-Life Data Download PDF
Chapter  23:  Economic Analyses alongside Cancer Clinical Trials Download PDF
Chapter  24:  Structural and Molecular Imaging in Cancer Therapy Clinical Trials Download PDF
Chapter  25:  Prognostic Factor Studies Download PDF
Chapter  26:  Predictive Modeling of Gene Expression Data Download PDF
Chapter  27:  Explained Variation and Explained Randomness for Proportional Hazards Models Download PDF
Chapter  28:  Prognostic Groups by Tree-Based Partitioning and Data Refinement Methods Download PDF
Chapter  29:  Risk Calculators Download PDF
Chapter  30:  Developing a Score Based upon Gene Expression Profiling and Validation Download PDF
Chapter  31:  Analysis of DNA Microarrays Download PDF
Chapter  32:  Methods for SNP Regression Analysis in Clinical Studies Download PDF
Chapter  33:  Forensic Bioinformatics Download PDF
prelims Download PDF
Plates Download PDF
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