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

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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:

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Editorial Reviews

From the Publisher
"A solid guide to designing clinical trials for medical scientists, especially those working in oncology, immune disease, and infectious disease…Three chapters address quality-of-life topics." -Selected for The First Clinical Research Bookshelf, "Essential Reading for Clinical Research Professionals," Journal of Clinical Research Best Practices, September 2012, Vol. 8, No. 9
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Product Details

  • ISBN-13: 9780123919113
  • Publisher: Elsevier Science
  • Publication date: 11/25/2011
  • Pages: 672
  • Sales rank: 976,967
  • Product dimensions: 7.50 (w) x 9.40 (h) x 1.50 (d)

Meet the Author

Dr. Tom Brody received his Ph.D. from the University of California at Berkeley in 1980 and has published several research articles in the areas of enzymology, metabolism and pharmacokinetics of folates and related amino acids. For his post-doctoral work, also at U.C. Berkeley, the author cloned, sequenced, and expressed an oncogene, and purified the encoded protein (xeroderma pigmentosum E; XPE). The XPE gene encodes a DNA repair protein. Later, he performed research on the structure of an antibody (natalizumab) used for treating multiple sclerosis. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author is a registered patent agent.

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Table of Contents

Abbreviations Introduction 1. The Origins of Drugs 2. Study Schema 3. Run-in Period 4. Inclusion and Stratification, Part I 5. Inclusion and Stratification, Part II 6. Blinding, Randomization, and Allocation 7. Placebo 8. Intent to Treat Versus Per Protocol 9. Statistics 10. Introduction to Endpoints for Clinical Trials in Pharmacology 11. Oncology Endpoint: Objective Response 12. Oncology Endpoint: Overall Survival and Progression-free Survival 13. Oncology Endpoint: Time to Progression 14. Oncology Endpoint: Disease-free Survival 15. Oncology Endpoint: Time to Distant Metastasis 16. Neoadjuvant Therapy Versus Adjuvant Therapy 17. Hematological Cancers 18. Biomarkers and Personalized Medicine 19. Endpoints for Immune Diseases 20. Endpoints for Infections 21. Health-related Quality of Life for Oncology 22. Health-related Quality of Life for Immune Disorders 23. Health-related Quality of Life and Infections 24. Drug Safety 25. Mechanism of Action, Part I 26. Mechanism of Action, Part II: Cancer 27. Mechanism of Action, Part III: Immune Diseases 28. Mechanism of Action, Part IV: Infections 29. Consent Forms 30. Package Inserts 31. Regulatory Approval 32. Patents

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