Randomised Controlled Clinical Trials

by Christopher J. Bulpitt

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.

Product Details

ISBN-13:	9781461379157
Publisher:	Springer US
Publication date:	10/08/2012
Edition description:	2nd ed. 1996
Pages:	437
Product dimensions:	6.10(w) x 9.25(h) x 0.04(d)

About the Author

Bulpitt, Christopher J. (Royal Postgraduate Medical School)

Table of Contents

1. Introduction.- 2. The history of controlled trials.- 3. Ethical considerations.- 4. The objectives of a randomised controlled trial.- 5. Validity of the results.- 6. Recruitment of subjects.- 7. How to ensure that the control and treated patients are similar in all important respects.- 8. How to ensure that the results are free of bias.- 9. The variability of results.- 10. How many subjects are required for a trial?.- 11. Different trial designs.- 12. Writing the prool.- 13. Information to be collected during a trial.- 14. The conduct of the trial.- 15. Analysis of the trial results.- 16. The evaluation of subjective well-being.- 17. Early trials on new drugs.- 18. The detection of adverse drug reactions.- 19. Failure to accept the results of randomised controlled trials.- 20. The advantages and disadvantages of randomised controlled trials.- 21. References.

Editorial Reviews

‘...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)

From the Publisher