Clinical Research in Private Practice
- 1st Edition - February 11, 2026
- Editors: Jason E. Pope, Timothy R. Deer, Steven M. Falowski, Dawood Sayed
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 3 7 5 0 - 1
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 3 7 5 1 - 8
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… Read more
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
Physicians, either in practice or in training, as well as research staff in practice or in training
1. Clinical Research, the Sequence
2. Clinical Research Personnel (CRC, CRA, CFE) and Resource Utilization
3. Role of Technology Based Solutions in Private Practice
4. Types of Clinical Research Methodology (inductive/deductive designs); case series, retrospective review, prospective work, power analysis)
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. Role of the research site Principal Investigator (PI)
14. The Clinic Research Coordinator (CRC)
15. The Clinical Research Assistant (CRA)
16. CRF (Case Report Forms)
17. Site qualification forms (SQF)
18. Clinical Trial Agreement (CTA) considerations
19. Investigational Review Board considerations
20. Study Budget Considerations
21. Site Budget Considerations
22. The Trial Master File (TMF)
23. Research Funding
24. Research Ethics
25. Statistical Analysis Methodologies in Clinica Research (ITT vs MITT)
26. Remote Data Acquisition and Monitoring
27. Research Monitoring Considerations
28. Considerations for selecting an EDC (Electronic Data Capture)
29. Research Liability
30. The Role of the Contract Research Organization (CRO)
2. Clinical Research Personnel (CRC, CRA, CFE) and Resource Utilization
3. Role of Technology Based Solutions in Private Practice
4. Types of Clinical Research Methodology (inductive/deductive designs); case series, retrospective review, prospective work, power analysis)
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. Role of the research site Principal Investigator (PI)
14. The Clinic Research Coordinator (CRC)
15. The Clinical Research Assistant (CRA)
16. CRF (Case Report Forms)
17. Site qualification forms (SQF)
18. Clinical Trial Agreement (CTA) considerations
19. Investigational Review Board considerations
20. Study Budget Considerations
21. Site Budget Considerations
22. The Trial Master File (TMF)
23. Research Funding
24. Research Ethics
25. Statistical Analysis Methodologies in Clinica Research (ITT vs MITT)
26. Remote Data Acquisition and Monitoring
27. Research Monitoring Considerations
28. Considerations for selecting an EDC (Electronic Data Capture)
29. Research Liability
30. The Role of the Contract Research Organization (CRO)
- Edition: 1
- Published: February 11, 2026
- Language: English
JP
Jason E. Pope
Dr. Pope is a leader in clinical research and innovation. He is involved with clinical trials encompassing many treatment strategies, including cellular therapy and regenerative medicine, medical devices to treat pain and wellness strategies. He is also focused on furthering education in the field of pain medicine. He has published over 100 peer-reviewed journals and spoken at numerous national and international conferences. He has served as the principal investigator for numerous national and international studies, started and clinical research organization, and helped numerous practices begin their research departments. When not helping his patients improve their quality of life, Dr. Pope enjoys spending time with his three children and writing.
Affiliations and expertise
Founder and CEO, Evolve Restorative Center, USATD
Timothy R. Deer
Timothy R. Deer is a clinical professor of anesthesiology at the West Virginia University School of Medicine, where he also received his medical degree. He completed his training in anesthesiology and pain medicine at the University of Virginia. Dr. Deer has published on a range of topics, including injection techniques, minimally invasive disc procedures, intrathecal drug delivery, and spinal cord and peripheral nerve stimulation. He lectures at many national and international symposiums and has been involved in the hands-on training of more than a thousand interventional pain specialists. He serves on the board of directors of the North American Neuromodulation Society and American Academy of Pain Medicine. He is a past chair of the committee on pain medicine of the American Society of Anesthesiologists, a member of the editorial board of the journal Neuromodulation, president of the West Virginia Society of Interventional Pain Physicians, and serves on several other boards and committees.
Affiliations and expertise
President and CEO, The Spine and Nerve Centers of the Virginias, USASF
Steven M. Falowski
Steven M. Falowski, MD, is the director of Functional Neurosurgery at St. Luke’s University Health Network in Bethlehem, PA, with a practice specializing in neuromodulation. He has developed a robust program within his practice that includes a Pain Center, a Movement Disorder Center, and an Epilepsy Monitoring Unit. Dr. Falowski completed neurosurgical residency training at Thomas Jefferson University in Philadelphia, with a focus on spinal cord stimulation and pain management, and a functional fellowship in both movement disorder and epilepsy at Rush University in Chicago with Roy Bakay, MD. Dr. Falkowski is a member of several board committees for functional neurosurgery, including North American Neuromodulation Society and the CNS/AANS Executive Pain Committee. He’s on the faculty of the Congress of Neurological Surgeons and the American Association of Neurological Surgeons. He is co-editor of Integrating Pain Treatment into Your Spine Practice.
Affiliations and expertise
director of Functional Neurosurgery at St. Luke’s University Health Network in Bethlehem, PADS
Dawood Sayed
Dr. Sayed’s areas of clinical interest are primarily focused on lower back pain, neck pain, cancer pain, nerve pain, neuropathy, degenerative disc disease, sacroiliitis, complex regional pain syndrome, neuropathy, radiculopathy, knee pain, shoulder pain, facet pain and tendon pain. He has expertise in multiple procedural treatments such as epidural steroid injections, nerve blocks, image-guided injections, spinal cord stimulation, minimally invasive spine surgery, minimally invasive lumbar decompression, Vertiflex Superion procedure, minimally invasive spine fusion, minimally invasive sacroiliac fusion, intrathecal pumps, radiofrequency ablation, kyphoplasty, vertebroplasty, Tenex/tenotomy procedure, Intracept® procedure and regenerative medicine procedures. Dr. Sayed is certified by the American Board of Anesthesiology with a subcertification in pain medicine. He completed his anesthesiology residency at the University of Kansas Medical Center and a pain medicine fellowship at the Tri-Institute of New York-Presbyterian/Weill Cornell Medical College/Memorial Sloan Kettering. He earned his medical degree from the University of Kansas School of Medicine.
Affiliations and expertise
Professor, University of Kansas Medical Center, USA