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Clinical Trials [electronic resource]: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

by Tom Brody
EBook; Book; Online
London : Academic, 2012.
9780123919137 (e-ISBN), 0123919134 (e-ISBN), 9780123919113 (p-ISBN), 0123919118 (p-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. 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.
Introduction. Abbreviations and definitions. Biography. 1. The Origins of Drugs 2. Introduction to regulated clinical trials 3. Run-in Period 4. Inclusion/exclusion criteria, stratification, and subgroups, Part I 5. Inclusion and stratification criteria, Part II 6. Randomization, allocation, and blinding 7. Placebo arm as part of clinical study design 8. Intent to treat analysis vs. per protocol analysis 9. Biostatistics 10. Introduction to endpoints for clinical trials in pharmacology 11. Endpoints in clinical trials on solid tumors : 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 in immune diseases 20. Endpoints in clinical trials on infections 21. Health-related quality of life 22. Health-related quality of life instruments for immune disorders 23. Health-related quality of life instruments 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. Index.
1 online resource (xxxiii, 638 pages) : illustrations
Includes bibliographical references and index.
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