Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and Fda and Ich Guidelines

Key Features

• Provides extensive coverage of the ''study schema'' and related features of study design
• Offers a ''hands-on'' reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design
• Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design
• Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials

Readership

Pharmaceutical scientists and pharmacologists, medical writers and physicians, nurses and pharmacists who plan and conduct clinical trials.

Contents

• Abbreviations
• Introduction

1. The Origins of Drugs
2. Study Schema
3. Run-in Period
4. Inclusion and Stratification, Part I
5. Inclusion and Stratification, Part II
6. Blinding, Randomization, and Allocation
7. Placebo
8. Intent to Treat Versus Per Protocol
9. Statistics
10. Introduction to Endpoints for Clinical Trials in Pharmacology
11. Oncology Endpoint: Objective Response
12. Oncology Endpoint: Overall Survival and Progression-free Survival
13. Oncology Endpoint: Time to Progression
14. Oncology Endpoint: Disease-free Survival
15. Oncology Endpoint: Time to Distant Metastasis
16. Neoadjuvant Therapy Versus Adjuvant Therapy
17. Hematological Cancers
18. Biomarkers and Personalized Medicine
19. Endpoints for Immune Diseases
20. Endpoints for Infections
21. Health-related Quality of Life for Oncology
22. Health-related Quality of Life for Immune Disorders
23. Health-related Quality of Life and Infections
24. Drug Safety
25. Mechanism of Action, Part I
26. Mechanism of Action, Part II: Cancer
27. Mechanism of Action, Part III: Immune Diseases
28. Mechanism of Action, Part IV: Infections
29. Consent Forms
30. Package Inserts
31. Regulatory Approval
32. Patents