Full Description
Clinical research is the tip of the spear for innovation and central in the development of improving safety and efficacy for patient centric care. Unfortunately, clinical research in academic practices is bogged down by inefficiency and infrequent regulatory oversight, thus leaving physicians unable to meet the clinical and research needs for driving innovation. Private practice is a valid practice cohort that can effectively, reliably, and reproducibly perform study related activities, for both FDA and non-FDA regulated studies, both industry-sponsored or investigator-initiated.Clinical Research in Private Practice fills a gap and provides a playbook for how to incorporate clinical research in a validated, safe, and compliant manner, allowing a needed meaningful contribution to the medical space, while concurrently maintaining fiduciary responsibility. Written for physicians by physicians.
Contents
1. Clinical research: The sequence
2. Clinical research personnel and resource utilization
3. Role of technology-based solutions for research in private practice interventional spine and pain practice
4. Types of clinical research methodology
5. Regulatory oversight
6. Sponsor relationships
7. The audit and monitoring site visit
8. Adapting day to day clinical workflow for clinical research
9. Meeting research related expectations
10. Publication and authorship
11. Winning the work
12. Role of the National Principal Investigator (PI)
13. The role of the research site principal investigator
14. The clinical research coordinator
15. The Clinical Research Assistant
16. Case report forms
17. Site qualification forms
18. Clinical trial agreements in private practice - importance, role and development
19. Institutional review board considerations
20. Study budget considerations for private practice
21. Site budget considerations for clinical research in private practice
22. The trial master file
23. Research funding
24. Practical research ethics for the private practice physician: From principle to procedure
25. Statistical analysis and methodologies in clinical research
26. Remote data acquisition and monitoring
27. Research monitoring considerations
28. Considerations for selecting an electronic data capture platform
29. Research liability
30. The role of the contract research organization
