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  • Book
    Tom Brody.
    Digital : ClinicalKey2016
    1. Origins of drugs -- 2. Clinical trial design -- 3. Run-in period -- 4. Inclusion/exclusion criteria, stratification, and subgroups -- part I -- 5. Inclusion/exclusion criteria, stratification, and subgroups -- part II -- 6. Blinding, randomization, and allocation -- 7. Placebo arm as part of clinical trial design -- 8. Intent-to-treat analysis versus per protocol analysis -- 9. Biostatistics -- part I -- 10. Biostatistics -- part II -- 11. Introduction to endpoints -- 12. Oncology endpoint -- objective response -- 13. Oncology endpoints : overall survival and progression-free survival -- 14. Oncology endpoints : time to progression -- 15. Oncology endpoint : disease-free survival -- 16. Oncology endpoint : time to distant metastasis -- 17. Neoadjuvant therapy versus adjuvant therapy -- 18. Hematological cancers -- 19. Biomarkers -- 20. Endpoints for immune diseases -- 21. Endpoints for infections -- 22. Health-related quality of life tools -- oncology -- 23. Health-related quality-of-life tools -- immune disorders -- 24. Health-related quality-of-life tools -- infections -- 25. Drug safety -- 26. Mechanism of action of diseases and drugs -- part I -- 27. Mechanism of action -- part II (cancer) -- 28. Mechanism of action -- part III (immune disorders) -- 29. Mechanisms of action -- part IV (infections) -- 30. Consent forms -- 31. Package inserts -- 32. Warning letters -- 33. Regulatory approval -- 34. Patents.