Statistical Design, Monitoring, and Analysis of Clinical Trials

Statistical Design, Monitoring, and Analysis of Clinical Trials

Principles and Methods

Shih, Weichung Joe; Aisner, Joseph

Taylor & Francis Ltd

10/2021

380

Dura

Inglês

9780367772444

15 a 20 dias

740

Descrição não disponível.
1. Overview. 2. Concepts and Methods of Statistical Designs. 3. Efficiency with Trade-Offs and Crossover Designs. 4. Sample Size and Power Calculations. 5. Analysis of Covariance and Stratified Analysis. 6. Regression Analysis of Survival Data 7. Sequential Designs and Methods-Part I: Expected Sample Size and Two-Stage Phase II Trials in Oncology 8. Sequential Designs and Methods-Part II: Monitoring Safety and Futility 9. Sequential Designs and Methods-Part III: Classical Group Sequential Trials 10. Monitoring the Maximum Information and Adaptive Sample-Size Designs 11. Multiplicity Issues and Methods for Controlling the Type-I Error Rate. 12.Clinical Trials with Predictive Biomarkers. 13. Seamless Phase II/III: Select-the-Winner Design. 14. Statistical Significance and p-Values. 15. Estimand, Intercurrent Events, and Missing Data.
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Interim Analyses;biostatistics in clinical trials;BLA;sample size and power calculation;Sample Size Calculation;analysis of covariance;Cumulative Distribution Function;sequential designs;WMW Test;Phase III group sequential trials;Adaptive Enrichment Design;two-stage Phase II cancer trials;Alpha Spending Function;stratified analysis;Group Sequential;adaptive group sequential procedures;Group Sequential Setting;missing data processes;Group Sequential Boundaries;Design and Analyze Clinical Trials;Data Monitoring Committee;Clinical Trial Investigators;DMC;clinical trial monitoring;GS Procedure;Fixed Sample Size Design;Missing Data;AHR;Marker Positive Patients;NMAR Model;Optimal Allocation Proportion;ANCOVA Model;ETDRS Letter;SAS Proc PHREG;Log Rank Test;Expected Sample Size;MAR Case