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.
1. Cover image - p. c 2. Title page - p. iii 3. Copyright - p. iv 4. Dedications - p. v 5. Contents - p. vii 6. Contributors - p. xxi 7. About the Editors - p. xxv 8. Foreword - p. xxvii 9. Chapter 1 Clinical research: The sequence - p. 1 10. Chapter 2 Clinical research personnel and resource utilization - p. 9 11. Chapter 3 Role of technology-based solutions for research in private practice interventional spine and pain practice - p. 15 12. Chapter 4 Types of clinical research methodology - p. 21 13. Chapter 5 Regulatory oversight - p. 29 14. Chapter 6 Sponsor relationships - p. 37 15. Chapter 7 The audit and monitoring site visit - p. 45 16. Chapter 8 Adapting day to day clinical workflow for clinical research - p. 53 17. Chapter 9 Meeting research related expectations - p. 59 18. Chapter 10 Publication and authorship - p. 69 19. Chapter 11 Winning the work - p. 75 20. Chapter 12 Role of the National Principal Investigator (PI) - p. 81 21. Chapter 13 The role of the research site principal investigator - p. 89 22. Chapter 14 The clinical research coordinator - p. 103 23. Chapter 15 The Clinical Research Assistant - p. 117 24. Chapter 16 Case report forms - p. 127 25. Chapter 17 Site qualification forms - p. 149 26. Chapter 18 Clinical Trial Agreements in Private Practice – Importance, Role and Development - p. 159 27. Chapter 19 Institutional review board considerations - p. 171 28. Chapter 20 Study budget considerations for private practice - p. 185 29. Chapter 21 Site budget considerations for clinical research in private practice - p. 205 30. Chapter 22 The trial master file - p. 211 31. Chapter 23 Research funding - p. 233 32. Chapter 24 Practical research ethics for the private practice physician: From principle to procedure - p. 251 33. Chapter 25 Statistical analysis and methodologies in clinical research - p. 267 34. Chapter 26 Remote data acquisition and monitoring - p. 279 35. Chapter 27 Research monitoring considerations - p. 289 36. Chapter 28 Considerations for selecting an electronic data capture platform - p. 295 37. Chapter 29 Research liability - p. 303 38. Chapter 30 The role of the contract research organization - p. 317 39. Index - p. 321
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.
1. Cover image - p. c 2. Title page - p. iii 3. Copyright - p. iv 4. Dedications - p. v 5. Contents - p. vii 6. Contributors - p. xxi 7. About the Editors - p. xxv 8. Foreword - p. xxvii 9. Chapter 1 Clinical research: The sequence - p. 1 10. Chapter 2 Clinical research personnel and resource utilization - p. 9 11. Chapter 3 Role of technology-based solutions for research in private practice interventional spine and pain practice - p. 15 12. Chapter 4 Types of clinical research methodology - p. 21 13. Chapter 5 Regulatory oversight - p. 29 14. Chapter 6 Sponsor relationships - p. 37 15. Chapter 7 The audit and monitoring site visit - p. 45 16. Chapter 8 Adapting day to day clinical workflow for clinical research - p. 53 17. Chapter 9 Meeting research related expectations - p. 59 18. Chapter 10 Publication and authorship - p. 69 19. Chapter 11 Winning the work - p. 75 20. Chapter 12 Role of the National Principal Investigator (PI) - p. 81 21. Chapter 13 The role of the research site principal investigator - p. 89 22. Chapter 14 The clinical research coordinator - p. 103 23. Chapter 15 The Clinical Research Assistant - p. 117 24. Chapter 16 Case report forms - p. 127 25. Chapter 17 Site qualification forms - p. 149 26. Chapter 18 Clinical Trial Agreements in Private Practice – Importance, Role and Development - p. 159 27. Chapter 19 Institutional review board considerations - p. 171 28. Chapter 20 Study budget considerations for private practice - p. 185 29. Chapter 21 Site budget considerations for clinical research in private practice - p. 205 30. Chapter 22 The trial master file - p. 211 31. Chapter 23 Research funding - p. 233 32. Chapter 24 Practical research ethics for the private practice physician: From principle to procedure - p. 251 33. Chapter 25 Statistical analysis and methodologies in clinical research - p. 267 34. Chapter 26 Remote data acquisition and monitoring - p. 279 35. Chapter 27 Research monitoring considerations - p. 289 36. Chapter 28 Considerations for selecting an electronic data capture platform - p. 295 37. Chapter 29 Research liability - p. 303 38. Chapter 30 The role of the contract research organization - p. 317 39. Index - p. 321
