Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials.

The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

part I|2 pages

General Issues

chapter 1|34 pages

Endpoints for Cancer Clinical Trials

ByStephen L. George, Xiaofei Wang, Herbert Pang

chapter 2|32 pages

Use of Historical Data

BySimon Wandel, Heinz Schmidli, Beat Neuenschwander

chapter 3|36 pages


ByDong Xi, Ekkehard Glimm, Frank Bretz

chapter 4|26 pages

Analysis of Safety Data

BySteven Snapinn, Qi Jiang

part II|2 pages

Early Phase Clinical Trials

chapter 5|34 pages

Development and Validation of Predictive Signatures

ByMichael C. Sachs, Lisa M. McShane

chapter 6|36 pages

Phase I Trials and Dose-finding

ByMark R. Conaway, Nolan A. Wages

chapter 7|30 pages

Design and Analysis of Phase II Cancer Clinical Trials

BySin-Ho Jung

part III|2 pages

Late Phase Clinical Trials

chapter 8|46 pages

Sample Size for Survival Trials in Cancer

ByEdward Lakatos

chapter 9|26 pages

Non-inferiority Trials

ByRajeshwari Sridhara, Thomas Gwise

chapter 10|24 pages

Quality of Life

ByDiane Fairclough

part IV|2 pages

Personalized Medicine

chapter 11|32 pages

Biomarker-based Clinical Trials

ByEdward L. Korn, Boris Freidlin

chapter 12|44 pages

Adaptive Clinical Trial Designs in Oncology

ByJ. Jack Lee, Lorenzo Trippa

chapter 13|38 pages

Dynamic Treatment Regimes

ByMarie Davidian, Anastasios (Butch) Tsiatis, and Eric Laber