Statistical Aspects Of The Design And Analysis Of Clinical Trials

Preface
According to Sir David Cox, the randomised controlled clinical trial
  W& Q# d2 O3 V8 b; I! ]1 ]) \% [is perhaps the outstanding contribution of statistics to 20th century
# J! K9 b+ b  n0 l6 j& d! mmedical research. Nowadays about 8000 such trials are undertaken
- h  F' S# r! F& v0 e' Lannually in all areas of medicine from the treatment of acne to the
prevention of cancer. Although the vast majority of these trials take
  s. a  j! h/ uplace away from the glare of public interest, some deal with issues
7 E! v; [; Z: Y1 O5 B. _8 ^8 ]that are controversial enough to make even the popular press; an
4 }, h: M8 h4 n5 pobvious example is the use of AZT for the treatment of AIDS.
$ M9 b3 B" P" R. X- |$ HThere are many excellent books available which give comprehen-
sive accounts of how clinical trials should be carried out and organ-
ised. Our aim is somewhat different; we attempt to give relatively
. q$ j3 L2 }+ {& [concise descriptions of the more statistical aspects of the design and
analysis of clinical trials, particularly those methods developed over
& U+ q1 \/ B& j0 K' @' R* {5 [' Jthe last decade or so. Topics discussed in this text include randomi-
- Y3 a' p: n; \# v1 U- Y/ {8 hsation, interim analyses, sample size determination, the analysis of
longitudinal data, Bayesian methods, survival analysis and meta-
analysis. Many examples are included alongside some of the neces-
sary technical material, the more difficult parts of which are confined
to tables. An Appendix gives details of relevant software. We hope
that our book will be useful to medical statisticians and others faced
  U: B( P. d* o- Ywith the often difficult problems of designing and analysing clinical
- k0 ?3 j/ ]; Y, g8 n$ atrials.
  f9 x# \0 Y! X& m/ c4 J, KOur thanks are due to Dr Sophia Rabe-Hesketh and Dr Sabine
Landau for reading the text and making many helpful suggestions,
to Professor Elizabeth Kuipers for allowing us to use the economic
data from her CBT trial in Chapter 4 and to Mrs Harriet Meteyard
) Y$ I6 ~9 u2 N% ifor help in compiling the references.