Randomised Controlled Clinical Trials

Overview

After 13 years there are new areas to discuss and more recent trials to be included. Good clinical practice; evaluation of quality of life; measurement of the benefit: risk comparison; determination of cost-effectiveness and cost utility; stopping rules for trials; meta-analysis and subgroup analysis are all new sections. The references are expanded from 305 to 512 and include the recent advances in trial design, such as the n-of-1 trials and megatrials, and up-to-date examples ...
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Paperback (2nd ed. 1997)
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Overview

After 13 years there are new areas to discuss and more recent trials to be included. Good clinical practice; evaluation of quality of life; measurement of the benefit: risk comparison; determination of cost-effectiveness and cost utility; stopping rules for trials; meta-analysis and subgroup analysis are all new sections. The references are expanded from 305 to 512 and include the recent advances in trial design, such as the n-of-1 trials and megatrials, and up-to-date examples to illustrate the points made in the 20 chapters.

The book contains black-and-white illustrations.

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Editorial Reviews

From the Publisher
'...a well-written basic introduction to the design and conduct of a clinical trial, referring to many cardiovascular examples along the way. It especially singles out topics of quality of life and failures of previous randomised trials. With that in mind, it is a useful contribution to a very important area in medical research.'
Controlled Clinical Trials, 6 (1985)
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Product Details

  • ISBN-13: 9781461379157
  • Publisher: Springer US
  • Publication date: 12/31/2012
  • Edition description: 2nd ed. 1997
  • Edition number: 2
  • Pages: 437
  • Product dimensions: 6.14 (w) x 9.21 (h) x 0.92 (d)

Table of Contents

Preface
1 Introduction 1
2 The history of controlled trials 7
3 Ethical considerations 17
4 The objectives of a randomised controlled trial 45
5 Different trial designs 57
6 How many subjects are required for a trial? 85
7 How to ensure that the results are free of bias 113
8 Writing the protocol 165
9 Recruitment of subjects 175
10 Information to be collected during a trial 183
11 The conduct of the trial - Good Clinical Practice 199
12 Stopping rules for trials 233
13 The variability and validity of results 245
14 Analysis of the results, subgroup and meta-analysis 269
15 The evaluation of subjective well-being and measurement of quality of life 301
16 The detection of adverse drug reactions 323
17 Measurement of the benefit: risk comparison, cost-effectiveness and cost-utility 331
18 Early trials on new drugs 341
19 Failure to accept the results of randomised controlled trials 351
20 The advantages and disadvantages of randomised controlled trials 379
References 387
Index 427
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