Clinical Trials in Oncology

Clinicians face considerable risks when designing trials and interpreting data. These risks are subtle and ever present. This book deals with all aspects of successful trials in a manner accessible to clinicians. After an introductory chapter, highlighted by a brief history of how clinical trials were accepted as the cornerstone of established medical practice, the authors present an overview of the statistical principles underlying the proper design of trials and the analysis of resultant data. The text emphasizes the importance of proper study design and data management, and explains why communication and partnership between statisticians and clinicians are vital to the conduct of a successful trial. Later chapters move on to cover some of the more contentious issues such as: advantages and disadvantages of multi-arm trials; when early stopping is justified; pitfalls to be avoided, such as analyzing survival by response or by dose; how and whether meta-analyses are justified. It is written for research oncologists and graduate students in biostatistics. It also provides essential information for statisticians involved with cancer clinical trials. It should be of interest to researchers in clinical oncology trials; students in Biostatistics.