Main description:

Features

Represents the first book to provide comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials

Describes the up-to-date theory and practice for model-assisted designs

Presents many practical challenges and issues arising from early-phase clinical trials

Illustrates with many real trial applications

Offers numerous tips and guidance on designing dose finding and optimization trials

Provides step-by-step illustration of using software to design trials

Develops a companion website (www.trialdesign.org) to provide easy-to-use software to assist learning and implementing model-assisted designs.

Contents:

1. Bayesian Statistics and Adaptive Designs. 1.1. Basics of Bayesian Statistics. 1.2. Bayesian Adaptive Designs. 1.2. Bayesian Adaptive Designs. 2. Algorithm and Model-Based Dose Finding Designs. 2.1 Introduction. 2.2. Traditional 3+3 Design. 2.3. Cohort Expansion. 2.4 Accelerated Titration Design. 2.5. Continual Reassessment Method. 2.6. Bayesian Model Averaging CRM. 2.7. Escalation with Overdose Control. 2.8. Bayesian Logistic Regression Method. 2.9. Software. 3. Model-Assisted Dose Finding Designs. 3.1. Introduction. 3.2. Modified Toxicity Probability Interval Design. 3.3. Keyboard Design. 3.4. 3.4 Bayesian Optimal Interval (BOIN) Design. 3.5. Operating Characteristics. 3.6. Software and Case Study. 4. Drug-Combination Trials. 4.1. Introduction. 4.2. Model-based Designs. 4.3. Model-assisted Designs. 4.4. Operating Characteristics. 4.5. Software and Case Study. 5. Late-Onset Toxicity. 5.1. A Common Logistical Problem. 5.2. Late-Onset Toxicities. 5.3. TITE-CRM. 5.4. TITE-BOIN. 5.5. A Unified Approach using "Effective" Data. 5.6. TITE-keyboard and TITE-mTPI designs. 5.7. Software and Case Study. 6. Incorporating Historical Data. 6.1. Historical Data and Prior Information. 6.2. Informative BOIN (iBOIN). 6.3. iKeyboard Design. 6.4. Operating Characteristics. 6.5. Software and Case Study. 7. Multiple Toxicity Grades. 7.1. Multiple Toxicity Grades. 7.2. gBOIN Accounting for Toxicity Grade. 7.3. Multiple-toxicity BOIN. 7.4. Software and Illustration. 8. Finding Optimal Biological Dose. 8.1. Introduction. 8.2. EffTox design. 8.3. U-BOIN Design. 8.4. BOIN12 Design. 8.5. TITE-BOIN12 Design. 8.6. Other Model-Assisted Phase I/II Designs. 8.7. Software and Case Study. Bibliography. Index.