Randomised Controlled Clinical Trials - Christopher J. Bulpitt

Randomised Controlled Clinical Trials

Buch | Softcover
437 Seiten
2012 | 2nd ed. 1996
Springer-Verlag New York Inc.
978-1-4613-7915-7 (ISBN)
213,99 inkl. MwSt
After 13 years there are new areas to discuss and more recent trials to be included. 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.
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.

1. Introduction.- 2. The history of controlled trials.- 3. Ethical considerations.- 4. The objectives of a randomised controlled trial.- 5. Different trial designs.- 6. How many subjects are required for a trial?.- 7. How to ensure that the results are free of bias.- 8. Writing the protocol.- 9. Recruitment of subjects.- 10. Information to be collected during a trial.- 11. The conduct of the trial — Good Clinical Practice.- 12. Stopping rules for trials.- 13. The variability and validity of results.- 14. Analysis of the results, subgroup and meta-analysis.- 15. The evaluation of subjective well-being and measurement of quality of life.- 16. The detection of adverse drug reactions.- 17. Measurement of the benefit; risk comparison, cost-effectiveness and cost-utility.- 18. Early trials on new drugs.- 19. Failure to accept the results of randomised controlled trials.- 20. The advantages and disadvantages of randomised controlled trials.- References.

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