Practical Handbook of Sample Size Guidelines for Clinical Trials is a concise guide and powerful software utility program that provides a valuable, non-technical blueprint for the design and analysis of survival clinical trials. This text and software allow clinical researchers to write more effective protocols or research grant proposals in a fraction of the time it would take them otherwise. Clinical researchers also gain insight into how biostatisticians analyze trial data and discover what "p-values" really tell them.
If you are a biostatistician or student, this book and software will be an indispensable tool for study design. Furthermore, no other book provides justification for survival analysis results at such an introductory level. The program increases your flexibility because it allows you to browse through various planning parameter configurations by changing one parameter at a time, circumventing the need to re-enter the set of planning parameters.
Practical Handbook of Sample Size Guidelines for Clinical Trials is ideal for biostatisticians, clinical oncologists, epidemiologists, public health specialists, hematologists, and other researchers who need a concise, easy-to-use tool for sample size determination.
HOW TO USE THE SAMPLE SIZE PROGRAM. Identification of Parameters. DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL TRIALS. Formulation of the Therapeutic Question. One-Sided vs. Two-Sided Question. Design of the Clinical Trial. Statistical Considerations. Conduct of the Trial. Analysis and Reporting of the Trial. Critical Elements. Binomial Comparison. Kaplan-Meier Comparison (Large Sample). Logrank Test. DERIVATION OF THE STATISTICAL RESULTS. Derivation of the Large Sample Distribution of the Logrank Statistic. Derivation of the Large Sample Distribution of the Kaplan-Meier Statistic. Difference between Kaplan-Meier Curves. Exponential Survival. Applications of the Logrank Test When Survival is Exponential. Exponential Survival with a Poisson Accrual Process. Extension to the Two-Sample Problem. Exponential Survival with "Up-Front" Accrual. Proportional Hazard Models and the Exponential Distribution. Consideration in Planning a Trial Under Proportional Hazards: Putting It All Together. Losses to Follow-Up and Sample Size Adjustment. Interpretation of the Program. Multi-Treatment Trials. Stratified Logrank Test. 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. Alternate Standard Error for the Kaplan-Meier Estimator. Connection between Kaplan-Meier and Binomial. FIGURES. APPENDIX I: A Review of Mathematical Statistics. Expected Value of a Function of a Random Vector. Special Distributions.