BookTom Brody.
Contents:
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.