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.- Presents a step-by-step guide for private practice physicians interested in research- Covers all aspects of integrating research from staffing, logistics, to workflow, funding and more- Written by practicing physicians in the field of research and clinical best practices
Table of Contents
1. Clinical research: The sequence2. Clinical research personnel and resource utilization3. Role of technology-based solutions for research in private practice interventional spine and pain practice4. Types of clinical research methodology5. Regulatory oversight6. Sponsor relationships7. The audit and monitoring site visit8. Adapting day to day clinical workflow for clinical research9. Meeting research related expectations10. Publication and authorship11. Winning the work12. Role of the National Principal Investigator (PI)13. The role of the research site principal investigator14. The clinical research coordinator15. The Clinical Research Assistant16. Case report forms17. Site qualification forms18. Clinical trial agreements in private practice – importance, role and development19. Institutional review board considerations20. Study budget considerations for private practice21. Site budget considerations for clinical research in private practice22. The trial master file23. Research funding24. Practical research ethics for the private practice physician: From principle to procedure25. Statistical analysis and methodologies in clinical research26. Remote data acquisition and monitoring27. Research monitoring considerations28. Considerations for selecting an electronic data capture platform29. Research liability30. The role of the contract research organization
