Edited by Steven Piantadosi, Johns Hopkins Oncology Center, Baltimore, USA

In recent years there has been an explosion of literature on clinical trials. However, the demand for accessible coverage of statistical methods - the crucial building blocks of medical research - has until now remained unmet. As modern medicine advances toward defining a speciality in clinical research, Clinical Trials: A Methodologic Perspective responds to this pressing need. Steven Piantadosi's hands-on approach, embracing a number of different trial designs and clinical fields, guides readers through the process of planning an experiment, putting together a study cohort, assessing data and reporting results, and addresses the problems that are likely to occur.

Supplemented with a data disk, numerous illustrations, a comprehensive bibliography and reference listings this straightforward and authoritative volume:

• Covers such vital design considerations as controlling bias and random error, allocating treatments and making decisions about terminating a study
• Focuses on concepts that unify all types of clinical trials
• Explores areas of controversy such as ethics and offers pragmatic information regarding allegations of fraud or misconduct
• Includes summaries and discussion questions in each chapter

Contents

• Preliminaries
• Clinical Trials and Research
• Ethical Considerations
• Clinical Trials as Experimental Designs
• Bias and Random Error
• Objectives and Endpoints
• Sample Size and Power
• The Study Cohort
• Treatment Allocation
• Data-Dependent Stopping
• Counting Patients and Events
• Estimating Clinical Effects
• Prognostic Factor Analyses
• Reporting
• Factorial Designs
• Cross-Over Designs
• Overviews/Meta-Analyses
• Fraud and Misconduct
• Data and Programs
• Notation and Terminology
• Bibliography
• Index