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

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Academic Press, Oct 25, 2011 - Medical - 672 pages
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Clinical 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.



  • Provides extensive coverage of the "study schema" and related features of study design
  • Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design
  • Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design
  • Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials
  • Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe

For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn

  

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Contents

1 The Origins of Drugs
1
2 Introduction to Regulated Clinical Trials
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
26 Mechanisms of Action Part II Cancer
493
27 Mechanisms of Action Part III Immune Disorders
503
28 Mechanisms of Action Part IV Infections
517
29 Consent Forms
535
30 Package Inserts
561
31 Regulatory Approval
577
32 Patents
607
Index
625
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