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Oncology clinical trials : = successful design, conduct, and analysis /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Oncology clinical trials :/ editors, William Kevin Kelly, DO (Professor, Department of Medical Oncology and Urology, Director, Division of Solid Tumor Oncology, Thomas Jefferson University, Associate Director of Clinical Research, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania), Susan Halabi, PhD (Professor, Department of Biostatistics & Bioinformatics, Duke University, Durham, North Carolina).
Reminder of title:	successful design, conduct, and analysis /
other author:	Kelly, Wm. Kevin
Description:	1 online resource (568 p.)
[NT 15003449]:	Oncology clinical trials : successful design, conduct, and analysis, second edition -- Dedication -- Contents -- Contributors -- Foreword -- Preface -- Share Oncology Clinical Trials: Successful Design, Conduct, and Analysis, Second edition -- Part I: Background and Introduction to Oncology Clinical Trials -- Chapter 1: The Changing Landscape of Clinical Research and Trials -- Chapter 2: Historical Perspectives of Oncology Clinical Trials -- Chapter 3: Ethical Principles Guiding Clinical Research -- Chapter 4: Industry Collaboration When Developing Novel Agents in Oncology -- Chapter 5: The Trials and Tribulations of Writing and Conducting an Investigator Initiated Trial -- Chapter 6: Writing a Consent Form -- Chapter 7: Why Do Clinical Trials Fail? -- Part II: Designing Oncology Clinical Trials -- Chapter 8: Choice of Endpoints in Cancer Clinical Trials -- Chapter 9: Design, Testing, and Estimation in Clinical Trials -- Chapter 10: Innovative Phase I Clinical Trials -- Chapter 11: Pharmacokinetics in Clinical Oncology -- Chapter 12: Dose Finding Using the Continual Reassessment Method -- Chapter 13: Design of Phase II Trials -- Chapter 14: Biomarkers in Confirmatory Clinical Trials -- Chapter 15: Bayesian Designs in Clinical Trials -- Chapter 16: Selection Designs -- Chapter 17: Phase III Oncology Clinical Trials -- Chapter 18: Design of Noninferiority Trials in Oncology -- Chapter 19: Design of Quality of Life Studies -- Chapter 20: Adaptive Designs -- Part III: Conducting Oncology Clinical Trials -- Chapter 21: Randomization -- Chapter 22: Case Report Form Development -- Chapter 23: Monitoring, Assessing, and Reporting Adverse Events -- Chapter 24: Dose Modification and Use of Ancillary Treatments in Investigational Studies in Clinical Trials -- Chapter 25: Assessment of Patient-Reported Outcomes in Industry-Sponsored Clinical Trials -- Chapter 26: Recruitment of Research Participants -- Chapter 27: Barriers to Oncology Clinical Trials -- Chapter 28: The Role of Novel Imaging Techniques in Clinical Trials -- Chapter 29: Practical Issues With Correlative Studies -- Chapter 30: The Development of Companion Diagnostics in Oncology Clinical Trials -- Part IV: Analyzing Results of Oncology Clinical Trials -- Chapter 31: Interim Analysis and Data Monitoring -- Chapter 32: Reporting of Results: Data Analysis and Interpretation -- Chapter 33: Statistical Considerations for Developing and Validating Prognostic Models of Clinical Outcomes -- Chapter 34: Statistical Evaluation of Surrogate Endpoints in Cancer Clinical Trials -- Chapter 35: Development and Validation of Genomic Signatures -- Chapter 36: Competing Risks Analysis in Clinical Trials -- Chapter 37: Systematic Reviews and Meta-Analysis -- Chapter 38: Statistical Methods for Genomics-Driven Clinical Studies -- Chapter 39: Handling Missing Data in Oncology Clinical Trials -- Part V: Special Considerations in Oncology Clinical Trials -- Chapter 40: Health-Related Quality of Life Studies in International Randomized Controlled Oncology Clinical Trials -- Chapter 41: The Economics of Oncology Clinical Trials -- Chapter 42: Special Considerations in Immunotherapy Trials -- Chapter 43: Special Considerations in Radiation Therapy Trials -- Chapter 44: Clinical Trials in Hematologic Malignancies -- Chapter 45: Issues in Recruiting Elderly, Underserved, Minority, and Rural Populations (and Solutions) -- Chapter 46: Telemedicine and Clinical Trials -- Part VI: Cooperative Groups, Regulatory and Governing Bodies -- Chapter 47: Cooperative Groups and Global Clinical Trials in the Future -- Chapter 48: The Evolution of the Drug Evaluation Process in Oncology: Regulatory Perspective -- Chapter 49: Clinical Trials in the Year 2025 -- Index.
Subject:	Cancer - Research -
Online resource:	https://portal.igpublish.com/iglibrary/search/SPCB0001987.html
ISBN:	0826168736

Oncology clinical trials : = successful design, conduct, and analysis /
Oncology clinical trials :successful design, conduct, and analysis /editors, William Kevin Kelly, DO (Professor, Department of Medical Oncology and Urology, Director, Division of Solid Tumor Oncology, Thomas Jefferson University, Associate Director of Clinical Research, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania), Susan Halabi, PhD (Professor, Department of Biostatistics & Bioinformatics, Duke University, Durham, North Carolina). - 2nd ed. - 1 online resource (568 p.)

Includes bibliographical references and index.

Oncology clinical trials : successful design, conduct, and analysis, second edition -- Dedication -- Contents -- Contributors -- Foreword -- Preface -- Share Oncology Clinical Trials: Successful Design, Conduct, and Analysis, Second edition -- Part I: Background and Introduction to Oncology Clinical Trials -- Chapter 1: The Changing Landscape of Clinical Research and Trials -- Chapter 2: Historical Perspectives of Oncology Clinical Trials -- Chapter 3: Ethical Principles Guiding Clinical Research -- Chapter 4: Industry Collaboration When Developing Novel Agents in Oncology -- Chapter 5: The Trials and Tribulations of Writing and Conducting an Investigator Initiated Trial -- Chapter 6: Writing a Consent Form -- Chapter 7: Why Do Clinical Trials Fail? -- Part II: Designing Oncology Clinical Trials -- Chapter 8: Choice of Endpoints in Cancer Clinical Trials -- Chapter 9: Design, Testing, and Estimation in Clinical Trials -- Chapter 10: Innovative Phase I Clinical Trials -- Chapter 11: Pharmacokinetics in Clinical Oncology -- Chapter 12: Dose Finding Using the Continual Reassessment Method -- Chapter 13: Design of Phase II Trials -- Chapter 14: Biomarkers in Confirmatory Clinical Trials -- Chapter 15: Bayesian Designs in Clinical Trials -- Chapter 16: Selection Designs -- Chapter 17: Phase III Oncology Clinical Trials -- Chapter 18: Design of Noninferiority Trials in Oncology -- Chapter 19: Design of Quality of Life Studies -- Chapter 20: Adaptive Designs -- Part III: Conducting Oncology Clinical Trials -- Chapter 21: Randomization -- Chapter 22: Case Report Form Development -- Chapter 23: Monitoring, Assessing, and Reporting Adverse Events -- Chapter 24: Dose Modification and Use of Ancillary Treatments in Investigational Studies in Clinical Trials -- Chapter 25: Assessment of Patient-Reported Outcomes in Industry-Sponsored Clinical Trials -- Chapter 26: Recruitment of Research Participants -- Chapter 27: Barriers to Oncology Clinical Trials -- Chapter 28: The Role of Novel Imaging Techniques in Clinical Trials -- Chapter 29: Practical Issues With Correlative Studies -- Chapter 30: The Development of Companion Diagnostics in Oncology Clinical Trials -- Part IV: Analyzing Results of Oncology Clinical Trials -- Chapter 31: Interim Analysis and Data Monitoring -- Chapter 32: Reporting of Results: Data Analysis and Interpretation -- Chapter 33: Statistical Considerations for Developing and Validating Prognostic Models of Clinical Outcomes -- Chapter 34: Statistical Evaluation of Surrogate Endpoints in Cancer Clinical Trials -- Chapter 35: Development and Validation of Genomic Signatures -- Chapter 36: Competing Risks Analysis in Clinical Trials -- Chapter 37: Systematic Reviews and Meta-Analysis -- Chapter 38: Statistical Methods for Genomics-Driven Clinical Studies -- Chapter 39: Handling Missing Data in Oncology Clinical Trials -- Part V: Special Considerations in Oncology Clinical Trials -- Chapter 40: Health-Related Quality of Life Studies in International Randomized Controlled Oncology Clinical Trials -- Chapter 41: The Economics of Oncology Clinical Trials -- Chapter 42: Special Considerations in Immunotherapy Trials -- Chapter 43: Special Considerations in Radiation Therapy Trials -- Chapter 44: Clinical Trials in Hematologic Malignancies -- Chapter 45: Issues in Recruiting Elderly, Underserved, Minority, and Rural Populations (and Solutions) -- Chapter 46: Telemedicine and Clinical Trials -- Part VI: Cooperative Groups, Regulatory and Governing Bodies -- Chapter 47: Cooperative Groups and Global Clinical Trials in the Future -- Chapter 48: The Evolution of the Drug Evaluation Process in Oncology: Regulatory Perspective -- Chapter 49: Clinical Trials in the Year 2025 -- Index.

The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents-including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.

Mode of access: World Wide Web.

ISBN: 0826168736Subjects--Topical Terms:

730090
Cancer
--ResearchIndex Terms--Genre/Form:

542853
Electronic books.

LC Class. No.: RC267

Dewey Class. No.: 362.196/994061

Oncology clinical trials : = successful design, conduct, and analysis /
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