Clinical Trials

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

Inbunden, Engelska, 2016

AvTom Brody,and Biogen IDEC (multiple sclerosis)) Brody, Tom (Consultant for Second Genome, Inc. (Crohn's disease), Rigel Pharmaceuticals (platelet disorder), PrimeGen Biotech (stem cell therapy), Regeneron Pharmaceuticals (broadly neutralizing antibodies for HIV)

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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.

Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more
Extensively covers the "study schema" and related features of study design
Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials
Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Produktinformation

Utgivningsdatum2016-03-14
Mått191 x 235 x 49 mm
Vikt2 740 g
FormatInbunden
SpråkEngelska
Antal sidor896
Upplaga2
FörlagElsevier Science
ISBN9780128042175

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Medicinsk utrustning och medicinska tekniker inom Medicin

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. Introduction to Clinical Trial Design3. Run-in Period4. Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I5. Inclusion and Stratification Criteria – Part II6. Randomization, Allocation, and Binding7. Intent to Treat Analysis vs. Per Protocol Analysis8. Biostatistics – Part I9. Biostatistics – Part II10. Introduction to Endpoints for Clinical Trials in Pharmacology11. Endpoints in Clinical Trials on Solid Tumors – Objective Response12. Oncology Endpoints: Overall Survival and Profession-Free Survival13. Oncology Endpoints: Time to Progression14. Oncology Endpoint: Disease-Free Survival15. Oncology Endpoint: Time to Distant Metastasis16. Neoadjuvant Therapy vs. Adjuvant Therapy17. Hematological Cancers18. Biomarkers and Personalized Medicine19. Endpoints in Immune Diseases20. Endpoints in Clinical Trials on Infections21. Health-Related Quality of Life22. Health-Related Quality of Life Instruments for Immune Disorders23. Health-Related Quality of Life Instruments and Infections24. Drug Safety25. Mechanisms of Action, Part I26. Mechanisms of Action, Part II – Cancer27. Mechanisms of Action, Part III – Immune Disorders 28. Mechanisms of Action, Part IV- Infections29. Consent Forms30. Package Inserts31. Regulatory Approval32. Patents

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