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 thlĂ/
![Revival: CRC Handbook of Sample Size Guidelines for Clinical Trials (1990) [Paperback]](/itemImage/2/9/8/9/2_3929593.jpg "Revival: CRC Handbook of Sample Size Guidelines for Clinical Trials (1990) [Paperback]")