Practical Handbook of Sample Size Guidelines for Clinical Trials Book

Ch. 1	How to Use the Sample Size Program	1
1.1	Identification of Parameters	2
Ch. 2	Design and Analysis of Randomized Clinical Trials	9
2.1	Formulation of the Therapeutic Question	9
2.2	Design of the Clinical Trial	11
2.3	Conduct of the Trial	20
2.4	Analysis and Reporting of the Trial	21
Ch. 3	Derivation of the Statistical Results	51
3.1	Derivation of the Large Sample Distribution of the Logrank Statistic	53
3.2	Derivation of the Large Sample Distribution of the Kaplan-Meier Statistic	63
3.3	Exponential Survival	86
3.4	Application of the Logrank Test When Survival is Exponential	93
3.5	Exponential Survival with a Poisson Accrual Process	98
3.6	Extension to the Two-Sample Problem	110
3.7	Exponential Survival with "Up-Front" Accrual	114
3.8	Proportional Hazard Models and the Exponential Distribution	117
3.9	Consideration in Planning a Trial Under Proportional Hazards: Putting It All Together	120
3.10	Losses to Follow-Up and Sample Size Adjustment	128
3.11	Interpretation of the Program	130
3.12	Multi-Treatment Trials	130
3.13	Stratified Logrank Test	137
3.14	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	140
3.15	Alternate Standard Error For the Kaplan-Meier Estimator	141
3.16	Connection Between Kaplan-Meier and Binomial	144
	Appendix I A Review of Mathematical Statistics	147
	Expected Value of a Function of a Random Vector (Definition)	155
	Special Distributions	162
	Transformations (Continuous Variables) (Consequence)	169
	Statistical Inference	189
	Sample Size Determination	197
	The Poisson Process	201
	References	210
	Index	211