Randomised Controlled Clinical Trials (1983)

Title: Randomised Controlled Clinical Trials
) {( n6 {- b  i  \6 h' JAuthor(s): Christopher J. Bulpitt (auth.)
Series: Developments in Biostatistics and Epidemiology 1
3 N+ y+ d' g" SPublisher: Springer US
$ v. a" i7 H- ~% h+ aYear: 1983
Edition: 1
. n! X$ q1 @& I$ L% bLanguage: English       
& h, p" G1 P* Q/ y% {( gPages: 262
$ q/ c( j4 J; x- t1 GISBN: 978-1-4757-6360-7, 978-1-4757-6358-4
Size: 5 MB (5157887 bytes)       
Extension: pdf
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4 @4 t: z! |7 T, V3 W9 qBradford Hill has defined a clinical trial as "A carefully and ethically designed experiment with the aim of answering some precisely framed question". This definition specifies a careful design and requires the provision of adequate controls. Random allocation of treatments to subjects is important to ensure is entitled that the treated and control groups are similar. Therefore this book Randomised Controlled Clinical Trials. We can define a randomised controlled trial by rewriting Bradford Hill's definition as follows, "A carefully and ethi- cally designed experiment which includes the provision of adequate and ap- propriate 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 trial, it is neither practicable nor desirable to divorce theory from practice, however the first ten chapters con- centrate mainly on theory, and the remainder focus on practice. The segment on trial design is followed by sections on writing the protocol, designing the forms, conducting the trial, and analysing the results. This book is meant to serve both as a reference manual and a practical guide to the design and performance of a trial.
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: d9 c: X/ o9 _$ Z2 FTable of contents :
Front Matter....Pages i-ix
9 u; u9 G6 U' JIntroduction....Pages 1-4
The History of Controlled Trials....Pages 5-11
Ethical Considerations....Pages 12-27
7 I* ?4 {1 r7 h+ gThe Objectives of a Randomised Controlled Trial....Pages 28-34
Validity of the Results....Pages 35-38
Recruitment of Subjects....Pages 39-43
4 s: F6 j& K, V" m' n. i8 dHow to Ensure that the Control and Treated Patients are Similar in all Important Respects....Pages 44-55
% N: O8 |& l: y% |1 KHow to Ensure that the Results are Free of Bias....Pages 56-79
6 R7 P4 H5 f, g8 L/ T: P' PThe Variability of Results....Pages 80-95
How Many Subjects are Required for a Trial?....Pages 96-117
Different Trial Designs....Pages 118-135
Writing the Protocol....Pages 136-143
Information to be Collected during a Trial....Pages 144-156
The Conduct of the Trial....Pages 157-178
6 L% V  z- k% j5 nAnalysis of the Trial Results....Pages 179-193
The Evaluation of Subjective Well-Being....Pages 194-208
, }# ?7 s0 u" r* `. z1 ~Early Trials on New Drugs....Pages 209-213
% C& o" n: B1 U: p8 j$ m7 QThe Detection of Adverse Drug Reactions....Pages 214-220
Failure to Accept the Results of Randomised Controlled Trials....Pages 221-238
+ l) u& Q2 L- n0 cThe Advantages and Disadvantages of Randomised Controlled Trials....Pages 239-243
2 `* o# t3 p9 QReferences....Pages 244-254
5 ]8 r1 \) k7 \4 q# OBack Matter....Pages 255-262

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