Randomised Controlled Clinical Trials, Second Edition Book

	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