This book is a 'how to do it' book on the practicalities of conducting clinical trials, systematic reviews and meta-analyses in cancer, showing how recent developments and current thinking can be implemented. Our aim is to provide a practical and common-sense guide on how to conduct cancer trials from start to finish - from bright ideas to published reports - giving plenty of examples to illustrate key points. Our intention has been to bring together current thinking on the design, conduct and analysis of trials into a single text and also to cover essential related matters such as patients' perspectives, systematic reviews and meta-analyses. We have tried to give emphasis to areas incompletely or inadequately covered elsewhere, including 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.
The book covers the principles and practice of planning, designing, conducting, analysing, reporting, and interpreting phase III trials, predominantly, but also single-arm and randomized phase II trials. Although many of the basic principles were established many years ago, there have been important developments in all these areas in recent years. Phase I studies, a separate and highly specialized area of clinical research, are only briefly mentioned.
We provide a working and reference text for a wide readership, including medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. We also hope that aspects of the book will prove helpful to a more general readership. Thus, trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in research related to clinical trials should, we hope, find this book helpful in understanding and fulfilling their roles.
It might be questioned why a book concerned specifically with clinical trials in cancer is needed. Obviously, many of the issues we discuss here are also relevant to trials in other diseases. Nevertheless, cancer has important features that are distinctive, if not unique. Malignant diseases are serious and often fatal, and have profound effects on patients and their families. The treatments used are often toxic, with small therapeutic indices and with hazards that may outweigh possible advantages. Improvements are often small and temporary. The primary outcome measure is usually the duration of survival, although its quality is also important. The management of patients frequently requires a high level of clinical expertise and supportive care within specialist treatment centres. There is therefore much to be said for a book in which the relevance of all these issues in the planning and conduct of clinical trials is given full weight.
The book is self-contained and we assume no prior specialized knowledge on the part of the reader. In writing it, it has been our intention to provide a coherent text rather than a series of disparate chapters, and so all authors contributed to all aspects of the book. Primary responsibilities for drafting each of the chapters lay as follows: Chapters 1, 7, 8
and 12 DJG, Chapters 3-5 and Chapter 10 SPS, Chapters 2 and 11 LAS, Chapter 6 RJS and Chapter 9 MKBP.
D.J.G., M.K.B.P., S.P.S., R.J.S. and, L.A.S. Medical Research Council Clinical Trials Unit, London June 2002
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