Clinical Trials. Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Content: 
Front-matter, Pages i,iii
Copyright, Page iv
Dedication, Page v
Acknowledgments, Pages xv-xvi
Preface, Pages xvii-xxi
Introduction, Pages xxiii-xxv
Abbreviations and Definitions, Pages xxvii-xxxi
Biography, Page xxxiii
Chapter 1 - The Origins of Drugs, Pages 1-15
Chapter 2 - Introduction to Regulated Clinical Trials, Pages 17-50
Chapter 3 - Run-in Period, Pages 51-61
Chapter 4 - Inclusion/Exclusion Criteria, Stratification, and Subgroups – Part I, Pages 63-89
Chapter 5 - Inclusion and Stratification Criteria – Part II, Pages 91-110
Chapter 6 - Randomization, Allocation, and Blinding, Pages 111-129
Chapter 7 - Placebo Arm as Part of Clinical Study Design, Pages 131-141
Chapter 8 - Intent to Treat Analysis vs. Per Protocol Analysis, Pages 143-164
Chapter 9 - Biostatistics, Pages 165-190
Chapter 10 - Introduction to Endpoints for Clinical Trials in Pharmacology, Pages 191-195
Chapter 11 - Endpoints in Clinical Trials on Solid Tumors – Objective Response, Pages 197-211
Chapter 12 - Oncology Endpoints: Overall Survival and Progression-free Survival, Pages 213-236
Chapter 13 - Oncology Endpoints: Time to Progression, Pages 237-250
Chapter 14 - Oncology Endpoint: Disease-Free Survival, Pages 251-261
Chapter 15 - Oncology Endpoint: Time to Distant Metastasis, Pages 263-270
Chapter 16 - Neoadjuvant Therapy versus Adjuvant Therapy, Pages 271-277
Chapter 17 - Hematological Cancers, Pages 279-325
Chapter 18 - Biomarkers and Personalized Medicine, Pages 327-353
Chapter 19 - Endpoints in Immune Diseases, Pages 355-367
Chapter 20 - Endpoints in Clinical Trials on Infections, Pages 369-382
Chapter 21 - Health-Related Quality of Life, Pages 383-400
Chapter 22 - Health-Related Quality of Life Instruments for Immune Disorders, Pages 401-410
Chapter 23 - Health-Related Quality of Life Instruments and Infections, Pages 411-414
Chapter 24 - Drug Safety, Pages 415-469
Chapter 25 - Mechanism of Action, Part I, Pages 471-491
Chapter 26 - Mechanisms of Action, Part II – Cancer, Pages 493-501
Chapter 27 - Mechanisms of Action, Part III – Immune Disorders, Pages 503-515
Chapter 28 - Mechanisms of Action, Part IV – Infections, Pages 517-533
Chapter 29 - Consent Forms, Pages 535-559
Chapter 30 - Package Inserts, Pages 561-575
Chapter 31 - Regulatory Approval, Pages 577-605
Chapter 32 - Patents, Pages 607-623
Index, Pages 625-638