Clinical Trials in Cancer Principles and Practice

Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered. This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.

1: Introduction, 2: The public perspective, 3: What type of trial is needed?, 4: Design issues for randomised trials, 5: Trial size, 6: Quality of life in clinical trials, 7: Putting plans into practice, 8: Conducting trials, 9: Analysis, 10: Reporting and interpreting results, 11: Systematic reviews and meta-analysis, 12: Benefits of an established trials centre and research group