Randomised Controlled Clinical Trials
Bradford Hill has defined a clinical trial as "A carefully and ethically designed experiment with the aim of answering some precisely framed question" [1]. This definition specifies a careful design and requires the provision of adequate controls. Random
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RANDOMISED CONTROLLED CLINICAL TRIALS
CHRISTOPHER J. BULPITT
Senior Lecturer in Epidemiology, Department of Medical Statistics and Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1 Honorary Senior Lecturer in Clinical Pharmacology, Royal Postgraduate Medical School, London and Honorary Consultant Physician, Hammersmith Hospital, London
Springer-Science+Business Media. B.Y.
Copyright 1983 © by Springer Science+Business Media Dordrecht Originally published by Martinus Nijhoff Publishers in 1983 Softcover reprint of the hardcover 1st edition 1983
Bulpitt, Christopher J. Randomised controlled trials. (Developments in biostatistics and epidemiology; v. 1) 1. Medical research-Methodology. 2. Human experimentation in medicine. I. Title. II. Series. [DNLM: 1. Clinical trials. 2. Research design. 3. Biometry. 4. Epidemiology. WI DE997VL v. 1 1 W 20.5 B939r] R850.B83 1983 615.5'0724 82-14544 ISBN 978-1-4757-6360-7 DOI 10.1007/978-1-4757-6358-4
ISBN 978-1-4757-6358-4 (eBook)
CONTENTS
Preface
vii
1. Introduction
1
2. The history of controlled trials 3. Ethical considerations
5
12
4. The objectives of a randomised controlled trial 5. Validity of the results
35
6. Recruitment of subjects
39
7. How to ensure that the control and treated patients are similar in all important respects
44
8. How to ensure that the results are free of bias 9. The variability of results 11. Different trial designs
56
80
10. How many subjects are required for a trial? 12. Writing the protocol
28
96
118 136
13. Information to be collected during a trial 14. The conduct of the trial
144
157
15. Analysis of the trial results
179
16. The evaluation of subjective well-being
194 v
vi Contents
17. Early trials on new drugs
209
18. The detection of adverse drug reactions
214
19. Failure to accept the results of randomised controlled trials
221
20. The advantages and disadvantages of randomised controlled trials 239 21. References
244
PREFACE
Bradford Hill has defined a clinical trial as "A carefully and ethically designed experiment with the aim of answering some precisely framed question" [1]. This definition specifies a careful design and requires the provision of adequate controls. Random allocation of treatments to subjects is important to ensure that the treated and control groups are similar. Therefore this book is entitled Randomised Controlled Clinical Trials. We can define a randomised controlled trial by rewriting Bradford Hill's definition as follows, "A carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomisation, so that precisely framed questions can be answered." I am a firm advocate ofRandomised Controlled Clinical Trials but intend to give a balanced view of the advantages and disadvantages of these ethical experiments. This book is directed primarily at the medical research worker, although certain chapters may find a wider application. When discussing a randomised controlled tr
