Description
Book SynopsisTable of Contents1. 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
