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CRC Handbook of Sample Size Guidelines for Clinical Trials

CRC Handbook of Sample Size Guidelines for Clinical Trials


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About the Book

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.

Table of Contents:
HOW TO USE THE SAMPLE SIZE TABLES. IDENTIFICATION OF PARAMETERS. REFERENCES. 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. Crucial Elements. Binomial Comparison. Kaplan-Meier Comparison (Large Sample). Logrank Test. REFERENCES. 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. APPLICATION 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 TABLES. MULTI-TREATMENT TRIALS. Type A. Type B. Type C. Type D. STRATIFIED LOGRANK TEST. Advice on Stratification. 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 WITH BINOMIAL. REFERENCES. FIGURES. APPENDIX I: A Review of Mathematical Statistics. APPENDIX II: Tables. INDEX.


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Product Details
  • ISBN-13: 9780849335426
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: CRC Press Inc
  • Height: 254 mm
  • No of Pages: 221
  • Returnable: N
  • Width: 178 mm
  • ISBN-10: 0849335426
  • Publisher Date: 25 Sep 1990
  • Binding: Hardback
  • Language: English
  • No of Pages: 221
  • Weight: 1724 gr


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CRC Handbook of Sample Size Guidelines for Clinical Trials
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