Clinical Trials (2nd Ed.) Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
Auteur : Brody Tom
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
- 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
Date de parution : 03-2016
Ouvrage de 896 p.
19x23.4 cm
Thèmes de Clinical Trials :
Mots-clés :
Active control; Add-on design; Adjuvant therapy; Adverse drug reaction; Adverse event; Allocation; Animal models; Autoimmune; Autoimmune disease; Best supportive care; Biomarkers; Blinding; Breast cancer; C-reactive protein; CIOMS; CONSORT diagram; CTCAE; Cancer; Carboplatin; Case report form; Cepecitabine; Cirrhosis; Cisplatin; Cladribine; Clinical study protocol; Clinical trial; Clinically isolated syndromes; Colon cancer; Colorectal cancer; Common Technical Document; Consent forms; Cyclophosophamide; Cytostatic; Cytotoxic; Cytotoxic T cells; DMC; Dacarbazine; Dasatinib; Data Monitoring Committee; Data and Safety Monitoring; Dendritic cell; Dimethyl fumarate; Disease staging; Disease-free survival; Docetaxel; Dose modification; Dose-escalation; Dose-limiting toxicity; Doxorubicin; Drug accountability; Drug candidate; Drug discovery; Drug safety; Drugdex; EMEA; Endpoints; Enrollment; Epitopes; Ethics; European Medicines Agency (EMA); Event-free survival; Exclusion criteria; Expedited review; FDA inspection; Federal Circuit; Fingolimod; Fluorescence in situ hybridization; Fluorouracil; Flutamidine; Food and Drug Administration (FDA); Form FDA 483; Gadolinium-enhancing; Gemcitabine; Gene array; Glatiramer; Goserelin; Guidance for Industry; HBV; HCV; HCV infection; HER2; HRQoL; Hazard ratio; Health-related quality of life (HRQoL); Helper T cells; Hepatitis C; Hepatocellular carcinoma; Herceptin; Hippocratic oath; ICH Guidelines; ITT; IVRS; Imatinib; Immune adjuvants; Inclusion criteria; Induction therapy; Infections; Informed consent; Institutional Review Board; Intent-to-treat