| Description |
1 online resource |
| Contents |
Front Cover; Novel Designs of Early Phase Trials for Cancer Therapeutics; Copyright Page; Dedication; Contents; List of Contributors; Preface; 1 Changing Landscape of Early Phase Clinical Trials: Beyond the Horizon; 1.1 Historical Perspective; 1.2 Current Trends; References; 2 Requirements for Filing an Investigational New Drug Application; 2.1 Exemptions to Filing an IND; 2.2 Types of IND Applications; 2.3 Regulatory and Administrative Components of an IND Application; 2.4 FDA IND Review; 2.5 IND Reporting Requirements; 2.5.1 Expedited Safety Reporting; 2.5.2 Annual Reporting |
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2.6 FDA Meetings2.7 IND Applications for Combination Therapies; 2.8 Applications for Companion Diagnostic Devices; 3 The Evolution of Phase I Trials, Past, Present, and Future: A Biostatistical Perspective; 3.1 Traditional Dose Finding: Toxicity-Based Designs; 3.1.1 Common Trial Designs for Toxicity-Based Dose Finding of Single Agents; 3.1.2 Toxicity-Based Dose-Finding Designs for Combinations; 3.1.3 Other Toxicity-Based Dose-Finding Designs; 3.1.4 (Re)defining Toxicity Endpoints; 3.2 Efficacy and Toxicity-Based Dose-Finding Designs; 3.3 Expansion Cohorts and Phase I/II Trials |
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3.4 Recent Trends in Phase I Trial Designs3.4.1 Breakthrough Therapy Designation and Its Impact on Trial Designs; 3.4.2 Statistical Challenges in Dose Finding Based in the Era of Immunotherapies and Targeted Agents; 3.5 Where Do We Go From Here: Recommendations for Optimal Early Phase Dose-Finding Trials; 3.5.1 Windows of Time for Evaluation of Toxicities; 3.5.2 Intrapatient Dose Escalation; 3.5.3 Delayed Clinical Responses, "Pseudo-Progression," and Duration of Response; 3.5.4 Measures of Efficacy for Dose Finding: Clinical Versus Correlative Outcomes; 3.5.5 Sample Size and Cohort Selection |
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3.5.6 Using Expansion Cohorts to Recalibrate Dose3.5.7 Abandon the Terms "Phase I, II, and III"; 3.6 Summary; References; 4 Evolving Early Phase Trial Designs: A Regulatory Perspective; 4.1 Introduction; 4.2 FDA Expedited Programs for Expediting the Development and Review of Drugs for Serious or Life-Threatening Conditions; 4.2.1 Fast Track Development Program Designation; 4.2.2 Breakthrough Therapy Development Program Designation; 4.2.3 Priority Review Designation of a New Drug Application/Biologics License Application; 4.2.4 Accelerated Approval and Regular Approval |
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4.3 Multiarm Expansion Cohorts in Early Phase Trials4.3.1 Traditional Drug Development Paradigm and Seamless Oncology Expansion Cohort Drug Development Paradigm; 4.3.2 Examples of Expansion Cohorts in Seamless Oncology Trials; 4.3.3 Regulatory Considerations of Seamless Oncology Expansion Cohort FIH Trials-Opportunities and Challenges; 4.3.3.1 Safety Considerations; 4.3.3.2 Efficacy Considerations; 4.4 Summary; References; 5 The Challenges of Implementing Multiarmed Early Phase Oncology Clinical Trials; 5.1 Introduction; 5.2 Evolution of Early Phase Clinical Trials; 5.2.1 Endpoints |
| Notes |
Includes index |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Online resource; title from digital title page (viewed on May 06, 2020) |
| Subject |
Antineoplastic agents -- Testing
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Drug development.
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Chemotherapy.
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Neoplasms
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Drug Therapy
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Antineoplastic Agents -- therapeutic use
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Antineoplastic Agents -- pharmacology
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MEDICAL -- Pharmacology.
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Chemotherapy
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Antineoplastic agents -- Testing
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Drug development
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| Form |
Electronic book
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| Author |
Kummar, Shivaani, editor.
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Takimoto, Chris, editor
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| ISBN |
9780128125700 |
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0128125705 |
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