Randomised Controlled Clinical Trials

✍ Scribed by Christopher J. Bulpitt (auth.)

• Publisher: Springer US
• Year: 1996
• Tongue: English
• Leaves: 436
• Edition: 2
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Front Matter....Pages i-ix
Introduction....Pages 1-6
The History of Controlled Trials....Pages 7-16
Ethical Considerations....Pages 17-43
The Objectives of a Randomised Controlled Trial....Pages 45-55
Different Trial Designs....Pages 57-83
How Many Subjects are Required For a Trial?....Pages 85-112
How to Ensure That the Results are Free of Bias....Pages 113-164
Writing The Protocol....Pages 165-174
Recruitment of Subjects....Pages 175-181
Information to be Collected During a Trial....Pages 183-198
The Conduct of the Trial — Good Clinical Practice....Pages 199-231
Stopping Rules For Trials....Pages 233-243
The Variability and Validity of Results....Pages 245-268
Analysis of the Results, Subgroup and Meta-Analysis....Pages 269-299
The Evaluation of Subjective Well-Being and Measurement of Quality of Life....Pages 301-322
The Detection of Adverse Drug Reactions....Pages 323-330
Measurement of the Benefit : Risk Comparison, Cost-Effectiveness and Cost-Utility.....Pages 331-340
Early Trials on New Drugs....Pages 341-349
Failure to Accept the Results of Randomised Controlled Trials....Pages 351-378
The Advantages and Disadvantages of Randomised Controlled Trials....Pages 379-385
Back Matter....Pages 387-437

✦ Subjects

Medicinal Chemistry; Medical Law; Health Informatics