Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH GuidelinesClinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.
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Contents
1 | |
17 | |
3 RunIn Period | 51 |
4 InclusionExclusion Criteria Stratification and Subgroups Part I | 63 |
5 Inclusion and Stratification Criteria Part II | 91 |
6 Randomization Allocation and Blinding | 111 |
7 Placebo Arm as Part of Clinical Study Design | 131 |
8 Intent to Treat Analysis vs Per Protocol Analysis | 143 |
18 Biomarkers and Personalized Medicine | 327 |
19 Endpoints in Immune Diseases | 355 |
20 Endpoints in Clinical Trials on Infections | 369 |
21 Healthrelated Quality of Life | 383 |
22 Healthrelated Quality of Life Instruments for Immune Disorders | 401 |
23 Healthrelated Quality of Life Instruments and Infections | 411 |
24 Drug Safety | 415 |
25 Mechanism of Action Part I | 471 |
9 Biostatistics | 165 |
10 Introduction to Endpoints for Clinical Trials in Pharmacology | 191 |
11 Endpoints In Clinical Trials on Solid Tumors Objective Response | 197 |
Overall Survival and Progressionfree Survival | 213 |
Time to Progression | 237 |
Diseasefree Survival | 251 |
Time to Distant Metastasis | 263 |
16 Neoadjuvant Therapy versus Adjuvant Therapy | 271 |
17 Hematological Cancers | 279 |
Other editions - View all
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and ... Tom Brody Limited preview - 2011 |
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and ... Tom Brody No preview available - 2016 |