Clinical Research in Private Practice
- 1st Edition - January 29, 2026
- Latest edition
- Editors: Jason E. Pope, Timothy R. Deer, Steven M. Falowski, Dawood Sayed
- Language: English
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
Jason E. Pope and Shawn Tomlinson
2. Clinical research personnel and resource utilization
Harjot S. Bhandal
3. Role of technology-based solutions for research in private practice interventional spine and pain practice
Hemant Kalia
4. Types of clinical research methodology
Zackary Fronk, Omar Dyara and Alaa Abd-Elsayed
5. Regulatory oversight
Alaa Abd-Elsayed and Daniel Talasazan
6. Sponsor relationships
Timothy R. Deer, Anuj Shah, Rosa Garcia, Alexa Moreira and Robin Mata
7. The audit and monitoring site visit
Hemant Kalia
8. Adapting day to day clinical workflow for clinical research
Rohan J. Kurian and Steven M. Falowski
9. Meeting research related expectations
Johnathan Goree, Shawn Shoham, Sarah Palmer and Carrie Hyde
10. Publication and authorship
Johnson S. Ho, Robert Heros, Alopi Patel and Christopher Gilligan
11. Winning the work
Dawood Sayed
12. Role of the National Principal Investigator (PI)
Nicholas Ildari and Timothy R. Deer
13. The role of the research site principal investigator
Gregory Moore, Alain Sayegh and Leila Sanghvi
14. The clinical research coordinator
Cara Davis, Alicia Lashley and DeVona Reese
15. The Clinical Research Assistant
Jennifer Lee, Amaad Sulahria, Spencer Luce and Jacob R. Lee
16. Case report forms
Reihaneh Moghadam, Mohammad Reza Rasouli, Alexandra Oseguera and Vafi Salmasi
17. Site qualification forms
Victoria Flower, Gary Schwartz and Samir Sheth
18. Clinical trial agreements in private practice – importance, role and development
Yeshvant A. Navalgund and Harman Chopra
19. Institutional review board considerations
Chau M. Vu and Rosa Garcia
20. Study budget considerations for private practice
Denis G. Patterson and David P. Russo
21. Site budget considerations for clinical research in private practice
Ashley Bailey-Classen
22. The trial master file
Shawn Tomlinson
23. Research funding
Marco Lawandy, Sandeep Yerra, Joshua Lewis and Adam Betcher
24. Practical research ethics for the private practice physician: From principle to procedure
Alexander M. Lopez, Brandon Lehman and Michael Oh
25. Statistical analysis and methodologies in clinical research
Tolga Suvar, Zachary Radwanski and Kevin Shi
26. Remote data acquisition and monitoring
Hemant Kalia and Tony George
27. Research monitoring considerations
Siddardth Umapathy and Mateusz Graca
28. Considerations for selecting an electronic data capture platform
David Curd, Zeinab Kheireddine, Kavya Kishen and Michael A. Fishman
29. Research liability
Charles Odonkor, Siri Bohacek and Salman Hirani
30. The role of the contract research organization
Boss Povieng and Timothy Lubeno
Jason E. Pope and Shawn Tomlinson
2. Clinical research personnel and resource utilization
Harjot S. Bhandal
3. Role of technology-based solutions for research in private practice interventional spine and pain practice
Hemant Kalia
4. Types of clinical research methodology
Zackary Fronk, Omar Dyara and Alaa Abd-Elsayed
5. Regulatory oversight
Alaa Abd-Elsayed and Daniel Talasazan
6. Sponsor relationships
Timothy R. Deer, Anuj Shah, Rosa Garcia, Alexa Moreira and Robin Mata
7. The audit and monitoring site visit
Hemant Kalia
8. Adapting day to day clinical workflow for clinical research
Rohan J. Kurian and Steven M. Falowski
9. Meeting research related expectations
Johnathan Goree, Shawn Shoham, Sarah Palmer and Carrie Hyde
10. Publication and authorship
Johnson S. Ho, Robert Heros, Alopi Patel and Christopher Gilligan
11. Winning the work
Dawood Sayed
12. Role of the National Principal Investigator (PI)
Nicholas Ildari and Timothy R. Deer
13. The role of the research site principal investigator
Gregory Moore, Alain Sayegh and Leila Sanghvi
14. The clinical research coordinator
Cara Davis, Alicia Lashley and DeVona Reese
15. The Clinical Research Assistant
Jennifer Lee, Amaad Sulahria, Spencer Luce and Jacob R. Lee
16. Case report forms
Reihaneh Moghadam, Mohammad Reza Rasouli, Alexandra Oseguera and Vafi Salmasi
17. Site qualification forms
Victoria Flower, Gary Schwartz and Samir Sheth
18. Clinical trial agreements in private practice – importance, role and development
Yeshvant A. Navalgund and Harman Chopra
19. Institutional review board considerations
Chau M. Vu and Rosa Garcia
20. Study budget considerations for private practice
Denis G. Patterson and David P. Russo
21. Site budget considerations for clinical research in private practice
Ashley Bailey-Classen
22. The trial master file
Shawn Tomlinson
23. Research funding
Marco Lawandy, Sandeep Yerra, Joshua Lewis and Adam Betcher
24. Practical research ethics for the private practice physician: From principle to procedure
Alexander M. Lopez, Brandon Lehman and Michael Oh
25. Statistical analysis and methodologies in clinical research
Tolga Suvar, Zachary Radwanski and Kevin Shi
26. Remote data acquisition and monitoring
Hemant Kalia and Tony George
27. Research monitoring considerations
Siddardth Umapathy and Mateusz Graca
28. Considerations for selecting an electronic data capture platform
David Curd, Zeinab Kheireddine, Kavya Kishen and Michael A. Fishman
29. Research liability
Charles Odonkor, Siri Bohacek and Salman Hirani
30. The role of the contract research organization
Boss Povieng and Timothy Lubeno
- Edition: 1
- Latest edition
- Published: January 29, 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, The Spine and Nerve Center of the Virginias; Clinical Professor, West Virginia University School of Medicine Charleston, West Virginia, United StatesSF
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, Functional Neurosurgery, Neurosurgical Associates of Lancaster, Lancaster, PA, United StatesDS
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, Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, Kansas, United StatesRead Clinical Research in Private Practice on ScienceDirect