Handbook of statistics in clinical oncology / edited by John Crowley, Antje Hoering.

Format:

Book

Contributor:

Crowley, John, 1946-

Hoering, Antje

ebrary, Inc.

Class of 1924 Book Fund.

Language:

English

Subjects (All):

Cancer--Research--Statistical methods.

Cancer.

Clinical trials--Statistical methods.

Clinical trials.

Neoplasms--therapy.

Research Design.

Clinical Trials as Topic.

Computational Biology.

Data Interpretation, Statistical.

Translational Research, Biomedical.

Cancer--Research.

Medical Subjects:

Neoplasms--therapy.

Research Design.

Clinical Trials as Topic.

Computational Biology.

Data Interpretation, Statistical.

Translational Research, Biomedical.

Physical Description:

1 online resource (xix, 635 pages) : illustrations (some color)

Edition:

Third edition.

Place of Publication:

Boca Raton, FL : CRC Press, [2012]

System Details:

text file

Summary:

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 has become common practice, and statistical methods on how to analyze 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 reassessement 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. Book jacket.

Contents:

Part I Phase I Trials

Chapter 1 Choosing a Phase I Design / Barry E. Storer Storer, Barry E. 3

Chapter 2 Dose-Finding Designs Based on the Continual Reassessment Method / John O'Quigley O'Quigley, John, Alexia Iasonos Iasonos, Alexia 21

Chapter 3 Pharmacokinetics in Clinical Oncology: Statistical Issues / Gary L. Rosner Rosner, Gary L., Peter Müller Müller, Peter, Simon Lunagomez Lunagomez, Simon, Patrick A. Thompson Thompson, Patrick A. 53

Chapter 4 Statistics of Phase 0 Trials / Larry Rubinstein Rubinstein, Larry 73

Chapter 5 CRM Trials for Assessing Toxicity and Efficacy / Sumithra J. Mandrekar Mandrekar, Sumithra J., Daniel J. Sargent Sargent, Daniel J. 85

Chapter 6 Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents / Antje Hoering Hoering, Antje, Michael LeBlanc LeBlanc, Michael, John J. Crowley Crowley, John J. 97

Part II Phase II Trials

Chapter 7 Overview of Phase II Clinical Trials / Stephanie Green Green, Stephanie 109

Chapter 8 Designs Based on Toxicity and Response / Gina R. Petroni Petroni, Gina R., Mark R. Conaway Conaway, Mark R. 125

Chapter 9 Designs Using Time-to-Event Endpoints/Single-Arm versus Randomized Phase II Designs / Catherine M. Tangen Tangen, Catherine M., John J. Crowley Crowley, John J. 139

Chapter 10 Phase II Selection Designs / P. Y. Liu Liu, P. Y., James Moon Moon, James, Michael LeBlanc LeBlanc, Michael 151

Chapter 11 Phase II with Multiple Subgroups: Designs Incorporating Disease Subtype or Genetic Heterogeneity / Michael LeBlanc LeBlanc, Michael, Cathryn Rankin Rankin, Cathryn, John J. Crowley Crowley, John J. 163

Chapter 12 Phase II/III Designs / Sally Hunsberger Hunsberger, Sally 175

Part III Phase III Trials

Chapter 13 Use of Covariates in Randomization and Analysis of Clinical Trials / Garnet L. Anderson Anderson, Garnet L., Michael LeBlanc LeBlanc, Michael, P.Y. Liu Liu, P.Y., John J. Crowley Crowley, John J. 185

Chapter 14 Factorial Designs with Time-to-Event Endpoints / Stephanie Green Green, Stephanie 199

Chapter 15 Early Stopping of Clinical Trials / Mary W. Redman Redman, Mary W. 211

Chapter 16 Noninferiority Trials / Kenneth J. Kopecky Kopecky, Kenneth J., Stephanie Green Green, Stephanie 229

Chapter 17 Phase III Trials for Targeted Agents / Antje Hoering Hoering, Antje, Michael LeBlanc LeBlanc, Michael, John J. Crowley Crowley, John J. 251

Chapter 18 Adaptive Trial Designs / Brian P. Hobbs Hobbs, Brian P., J. Jack Lee Lee, J. Jack 265

Chapter 19 Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit / William E. Barlow Barlow, William E. 293

Chapter 20 Software for Design and Analysis of Clinical Trials / J. Jack Lee Lee, J. Jack, Nan Chen Chen, Nan 305

Chapter 21 Cure-Rate Survival Models in Clinical Trials / Megan Othus Othus, Megan, John J. Crowley Crowley, John J., Bart Barlogie Barlogie, Bart 325

Chapter 22 Design and Analysis of Quality-of-Life Data, / Andrea B. Troxel Troxel, Andrea B., Carol M. Moinpour Moinpour, Carol M. 339

Chapter 23 Economic Analyses alongside Cancer Clinical Trials / Dean A. Regier Regier, Dean A., Scott D. Ramsey Ramsey, Scott D. 369

Chapter 24 Structural and Molecular Imaging in Cancer Therapy Clinical Trials / Brenda F. Kurland Kurland, Brenda F., David A. Mankoff Mankoff, David A. 387

Part IV Exploratory and High-Dimensional Data Analyses

Chapter 25 Prognostic Factor Studies / Martin Schumacher Schumacher, Martin, Norbert Holländer Holländer, Norbert, Guido Schwarzer Schwarzer, Guido, Harold Binder Binder, Harold, Willi Sauerbrei Sauerbrei, Willi 415

Chapter 26 Predictive Modeling of Gene Expression Data / Alexander Hapfelmeier Hapfelmeier, Alexander, Waheed Babatunde Yahya Yahya, Waheed Babatunde, Robert Rosenberg Rosenberg, Robert, Kurt Ulm Ulm, Kurt 471

Chapter 27 Explained Variation and Explained Randomness for Proportional Hazards Models / John O'Quigley O'Quigley, John, Ronghui Xu Xu, Ronghui 487

Chapter 28 Prognostic Groups by Tree-Based Partitioning and Data Refinement Methods / Michael LeBlanc LeBlanc, Michael, John J. Crowley Crowley, John J. 505

Chapter 29 Risk Calculators / Donna Pauler Ankerst Ankerst, Donna Pauler, Yuanyuan Liang Liang, Yuanyuan 529

Chapter 30 Developing a Score Based upon Gene Expression Profiling and Validation / Pingping Qu Qu, Pingping, John D. Shaughnessy Jr. Shaughnessy, John D., Jr., Bait Barlogie Barlogie, Bait, John J. Crowley Crowley, John J. 555

Chapter 31 Analysis of DNA Microarrays / Shigeyuki Matsui Matsui, Shigeyuki, Hisashi Noma Noma, Hisashi 569

Chapter 32 Methods for SNP Regression Analysis in Clinical Studies: Selection, Shrinkage, and Logic / Michael LeBlanc LeBlanc, Michael, Bryan Goldman Goldman, Bryan, Charles Kooperberg Kooperberg, Charles 591

Chapter 33 Forensic Bioinformatics / Keith A. Baggerly Baggerly, Keith A., Kevin R. Coombes Coombes, Kevin R. 605.

Notes:

Description based on print version record.

Rev. ed. of: Handbook of statistics in clinical oncology / [edited by] John Crowley, Donna Pauler Ankerst. 2006.

Includes bibliographical references and index.

Electronic reproduction. Palo Alto, Calif. Available via World Wide Web.

Local Notes:

Acquired for the Penn Libraries with assistance from the Class of 1924 Book Fund.

Other Format:

Print version: Handbook of statistics in clinical oncology.

ISBN:

143986201X

9781439862018

Publisher Number:

99949255560

Access Restriction:

Restricted for use by site license.