Model-assisted Bayesian designs for dose finding and optimization : methods and applications

著者

    • Yuan, Ying (Professor of biostatistics)
    • Lin, Ruitao
    • Lee, J. Jack

書誌事項

Model-assisted Bayesian designs for dose finding and optimization : methods and applications

Ying Yuan, Ruitao Lin, J. Jack Lee

（Chapman & Hall/CRC biostatistics series）

C&Hall/CRC Press, 2023

First edition

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注記

Content Type: text (rdacontent), Media Type: unmediated (rdamedia), Carrier Type: volume (rdacarrier)

Includes bibliographical references and index

Summary: "Bayesian adaptive designs provide a critical approach to improve the efficiency and success rate of drug development that has been embraced by the US Food and Drug Administration (FDA). This is particularly important for early phase trials as they forms the basis for the development and success of subsequent phase II and III trials. The objective of this book is to describes the state-of-the-art model-assisted designs to faciliate and accelerate the use of novel adaptive designs for early phase clinical trials. Model-assisted designs possess avant-garde features where superiority meets simplicity. Model-assisted designs enjoy exceptional performance comparable to more complicated model-based adaptive designs, yet their decision rules often can be pre-tabulated and included in the protocol-making implementation as simple as conventional algorithm-based designs. An example is the Bayesian optimal interval (BOIN) design, the first dose-finding design to receive the fit-for-purpose designation from the

収録内容

  • Bayesian Statistics and Adaptive Designs
  • Algorithm and Model-Based Dose Finding Designs
  • Model-Assisted Dose Finding Designs
  • Drug-Combination Trials
  • Late-Onset Toxicity
  • Incorporating Historical Data
  • Multiple Toxicity Grades
  • Finding Optimal Biological Dose

内容説明・目次

内容説明

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.

目次

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.

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