Clinical Trials, Second Edition: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

__**Clinical Trials, Second Edition,**__ offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of __Clinical Trials__ is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.* Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more * Extensively covers the "study schema" and related features of study design * Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials * Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers Content: Front-matter,Copyright,Dedication,Acknowledgments,Preface,Introduction,Abbreviations and Definitions,BiographiesEntitled to full textChapter 1 - Origins of Drugs, Pages 1-30 Chapter 2 - Clinical Trial Design, Pages 31-68 Chapter 3 - Run-In Period, Pages 69-81 Chapter 4 - Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part I, Pages 83-113 Chapter 5 - Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part II, Pages 115-132 Chapter 6 - Blinding, Randomization, and Allocation, Pages 133-153 Chapter 7 - Placebo Arm as Part of Clinical Trial Design, Pages 155-172 Chapter 8 - Intent-to-Treat Analysis Versus Per Protocol Analysis, Pages 173-201 Chapter 9 - Biostatistics—Part I, Pages 203-226 Chapter 10 - Biostatistics—Part II, Pages 227-245 Chapter 11 - Introduction to Endpoints, Pages 247-252 Chapter 12 - Oncology Endpoint—Objective Response, Pages 253-268 Chapter 13 - Oncology Endpoints: Overall Survival and Progression-Free Survival, Pages 269-288 Chapter 14 - Oncology Endpoints: Time to Progression, Pages 289-301 Chapter 15 - Oncology Endpoint: Disease-Free Survival, Pages 303-312 Chapter 16 - Oncology Endpoint: Time to Distant Metastasis, Pages 313-319 Chapter 17 - Neoadjuvant Therapy Versus Adjuvant Therapy, Pages 321-330 Chapter 18 - Hematological Cancers, Pages 331-376 Chapter 19 - Biomarkers, Pages 377-419 Chapter 20 - Endpoints for Immune Diseases, Pages 421-436 Chapter 21 - Endpoints for Infections, Pages 437-450 Chapter 22 - Health-Related Quality of Life Tools—Oncology, Pages 451-468 Chapter 23 - Health-Related Quality-of-Life Tools—Immune Disorders, Pages 469-477 Chapter 24 - Health-Related Quality-of-Life Tools—Infections, Pages 479-482 Chapter 25 - Drug Safety, Pages 483-568 Chapter 26 - Mechanism of Action of Diseases and Drugs—Part I, Pages 569-594 Chapter 27 - Mechanism of Action—Part II (Cancer), Pages 595-609 Chapter 28 - Mechanism of Action—Part III (Immune Disorders), Pages 611-633 Chapter 29 - Mechanisms of Action—Part IV (Infections), Pages 635-662 Chapter 30 - Consent Forms, Pages 663-687 Chapter 31 - Package Inserts, Pages 689-718 Chapter 32 - Warning Letters, Pages 719-779 Chapter 33 - Regulatory Approval, Pages 781-828 Chapter 34 - Patents, Pages 829-845 Index, Pages 847-863 Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.

• Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more
• Extensively covers the "study schema" and related features of study design
• Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials
• Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

"Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials."--Résumé de l'éditeur