Clinical Trials

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.
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Product details

  • Paperback | 638 pages
  • 197 x 240mm | 1,820g
  • Academic Press Inc
  • San Diego, United States
  • English
  • Reprint
  • Approx. 100 illustrations
  • 0128102578
  • 9780128102572
  • 1,530,695

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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Review quote

"...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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About Tom Brody

Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. His 20 research publications concern the metabolism and pharmacology of folates, cloning an anti-cancer gene (XPE gene), and the structure of an antibody (natalizumab) used for treating multiple sclerosis. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author has 16 years of training and experience in the Code of Federal regulations, as it applies to pharmaceuticals and clinical trial design.
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