1. Why Do Clinical Research?
2. How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect
3. Choosing a Study
4. Starting a Clinical Research Team
5. Developing a Budget
6. Negotiating a Contract
7. Writing a Great Consent
8. Starting the Study
9. Institutional Review Board (IRB)
11. Getting Subjects Through the Door
12. The Screening Visit
13. Follow-Up Subject Visits
14. Maintaining Subject Retention and Avoiding Study Fatigue
15. Adverse Events and Protocol Deviations
16. Contract Research Organizations and Monitors
17. Annual Reviews and Financial Disclosures
18. Finishing the Study
19. Staff Training and Incentives
20. Study Closeout
21. Acing an Audit
22. Expanding the Team
This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit.
Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field.
Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting.
• The first book of its kind discussing how to develop a successful team approach to clinical research
• Covers launching, performing and completing the study, with tips on team building and patient selection and retention
• Practical and user-friendly in all clinical settings
Cara East, MD, FACP, Texas Heart Center, Director, Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX, USA