Clinical Trials

Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Tom Brody (Autor)

Buch | Hardcover

896 Seiten

2016 | 2nd edition
Academic Press Inc (Verlag)
978-0-12-804217-5 (ISBN)

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Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.

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 Drugs
2. Introduction to Clinical Trial Design
3. Run-in Period
4. Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I
5. Inclusion and Stratification Criteria – Part II
6. Randomization, Allocation, and Binding
7. Intent to Treat Analysis vs. Per Protocol Analysis
8. Biostatistics – Part I
9. Biostatistics – Part II
10. Introduction to Endpoints for Clinical Trials in Pharmacology
11. Endpoints in Clinical Trials on Solid Tumors – Objective Response
12. Oncology Endpoints: Overall Survival and Profession-Free Survival
13. Oncology Endpoints: Time to Progression
14. Oncology Endpoint: Disease-Free Survival
15. Oncology Endpoint: Time to Distant Metastasis
16. Neoadjuvant Therapy vs. 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. Mechanisms of Action, Part I
26. Mechanisms of Action, Part II – Cancer
27. Mechanisms of Action, Part III – Immune Disorders
28. Mechanisms of Action, Part IV- Infections
29. Consent Forms
30. Package Inserts
31. Regulatory Approval
32. Patents

Erscheinungsdatum	18.03.2016
Zusatzinfo	Approx. 100 illustrations; Illustrations
Verlagsort	San Diego
Sprache	englisch
Maße	191 x 235 mm
Gewicht	2740 g
Themenwelt	Medizin / Pharmazie
ISBN-10	0-12-804217-6 / 0128042176
ISBN-13	978-0-12-804217-5 / 9780128042175
Zustand	Neuware