Clinical Trials
Academic Press Inc (Verlag)
978-0-12-391911-3 (ISBN)
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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.
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 Clinical Trials, 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.
1. The Origins of Drugs2. Study Schema3. Run-in Period4. Inclusion and Stratification, Part I5. Inclusion and Stratification, Part II6. Blinding, Randomization, and Allocation7. Placebo8. Intent to Treat Versus Per Protocol9. Statistics10. Introduction to Endpoints for Clinical Trials in Pharmacology11. Oncology Endpoint: Objective Response12. Oncology Endpoint: Overall Survival and Progression-free Survival13. Oncology Endpoint: Time to Progression14. Oncology Endpoint: Disease-free Survival15. Oncology Endpoint: Time to Distant Metastasis16. Neoadjuvant Therapy Versus Adjuvant Therapy17. Hematological Cancers18. Biomarkers and Personalized Medicine19. Endpoints for Immune Diseases20. Endpoints for Infections21. Health-related Quality of Life for Oncology22. Health-related Quality of Life for Immune Disorders23. Health-related Quality of Life and Infections24. Drug Safety25. Mechanism of Action, Part I26. Mechanism of Action, Part II: Cancer27. Mechanism of Action, Part III: Immune Diseases28. Mechanism of Action, Part IV: Infections29. Consent Forms30. Package Inserts31. Regulatory Approval32. Patents
| Verlagsort | San Diego |
|---|---|
| Sprache | englisch |
| Maße | 191 x 235 mm |
| Gewicht | 1540 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| ISBN-10 | 0-12-391911-8 / 0123919118 |
| ISBN-13 | 978-0-12-391911-3 / 9780123919113 |
| Zustand | Neuware |
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