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E-raamat: Revival: CRC Handbook of Sample Size Guidelines for Clinical Trials (1990)

(University of Florida, Gainesville, USA)
  • Formaat: 862 pages
  • Sari: CRC Press Revivals
  • Ilmumisaeg: 15-Jan-2019
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9781351366250
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Revival: CRC Handbook of Sample Size Guidelines for Clinical Trials (1990)Suurem pilt
  • Formaat: 862 pages
  • Sari: CRC Press Revivals
  • Ilmumisaeg: 15-Jan-2019
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9781351366250
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The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

1. How to use the sample size tables
2. Identification of parameters
3. References
4. Design and analysis of randomized clinical trials
5. Formulation of the therapeutic question
6. One sided vs. Two-sided question
7. Design of the clinical trial
8. Statistical considerations
9. Conduct of the trial
10. Analysis and reporting of the trial
11. Crucial elements
12. Binomial comparison
13. Kaplan-meier comparison (large sample)
14. Logrank test
15. References
16. Derivation of the statistical results
17. Derivation of the large sample distribution of the logrank statistic
18. Derivation of the large sample distribution of the kaplan-meier statistic
19. Difference between kaplan-meier curves
20. Exponential survival
21. Application of the logrank test when survival is exponential
22. Exponential survival with a poisson accrual process
23. Extension to the two-sample problem
24. Exponential survival with "up-front" accrual
25. Proportional hazard models and the exponential distribution
26. Consideration in planning a trial under proportional hazards: putting it all together
27. Losses to follow-up and sample size adjustment
28. Interpretation of the tables
29. Multi-treatment trials
30. Type a
31. Type b
32. Type c
33. Type d
34. Stratified logrank test
35. Advice on stratification
36. Intuitive justification why the logrank test and kaplan-meier estimation for actual accrual process behave in the limit in the same way as the fixed binomial assumption
37. Alternate standard error for the kaplan-meier estimator
38. Connection between kaplan-meier with binomial
39. References
40. Figures. Appendix i: a review of mathematical statistics. Appendix ii: tables. Index.

Jonathan Shuster is Research Professor and Biostatistician, General Clinical Research Center at the University of Florida.
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Püsilink: https://www.kriso.ee/db/97813513662506e.html