Gregg H. Gilbert, DDS, MBA, FAAHD, FACD for the CONDOR Collaborative Group

1. Developing practice-based research: a North American perspective Gregg H. Gilbert, DDS, MBA, FAAHD, FACD for the CONDOR Collaborative Group Network Chair of “DPBRN” (www.DPBRN.org) Professor and Chair, Department of Diagnostic Sciences University of Alabama at Birmingham School of Dentistry “Emerging Issues in Practice-Based Research” symposium 9:00 AM, Wednesday, April 1, 2009 Convention Center Room D128 Miami Beach, FL Support: U.S. National Institutes of Health grants U01-DE-16746 and U01-DE-16747

2. What is a dental practice-based research network (PBRN)? A group of dental practices that has affiliated to investigate research questions and to engage in sharing experiences and expertise.

3. What is a dental practice-based research network (PBRN)? A group of dental practices that has affiliated to investigate research questions and to engage in sharing experiences and expertise. The network conducts research that is done by and about the “real world” of daily clinical practice, where the overwhelming majority of the population receives its dental care.

4. How is PBRN research different from other types of research? Laboratory Clinical trials Practice-based Community- research trials in research based academic research settings

5. How is PBRN research different from other types of research? Laboratory Clinical trials Practice-based Community- research trials in research based academic research settings ______________________________________________________________ not ready for not ready for not ready for not ready for humans1 patients practices communities 1 most of the “not ready” terms adapted with revision from James W. Mold, MD, MPH

6. CONDOR: a collaborative of three NIDCR-funded networks • DPBRN: administrative base at UAB • NWPRECEDENT: admin. based at UW, OHSU • PEARL: administrative base at NYU • Collaborate on: • infrastructure issues • some research projects • data standardization and curation

7. Other North American dental PBRNs • CROWN (Community Res. for Oral Wellness Network) • general dentists in northern Ohio • PROH (Practice-based Research in Oral Health) • Oregon and southwest Washington

8. Other North American dental PBRNs • UTHSCSA Orthodontic PBRN, based in San Antonio

9. Three-Network Organization CONDOR organization National Monitoring Committee NIDCR CONDOR DSMB DPBRN CONDOR Directors Committee CONDOR Informatics Committee NWPRECEDENT CONDOR Publications Committee PEARL CONDOR PIRG CONDOR Protocol Rev Committee

10. Geographic areas currently covered by the CONDOR PBRNs

11. Participating practitioners (n ≈ 600) after Year 04 • Alabama • Florida • Georgia • Mississippi • Minnesota • Oregon • Washington • Scandinavia Sweden Denmark Norway • Connecticut • Delaware • Maryland • Massachusetts • Michigan • New Hampshire • New Jersey • New York • Ohio • Pennsylvania • Rhode Island • Virginia • Vermont • Washington, D.C. • Idaho • Utah • Montana • Washington • Oregon

12. Basic organizational structure of the individual CONDOR PBRNs • Network Chair group • Coordinating Center group • Executive Committee • NIDCR staff • Protocol Review Committee • IRBs or ethics committees • DSMBs and OSOCs • NIDCR PBRN Monitoring Committee

13. Basic organizational structure of the individual CONDOR PBRNs • Network Chair group • Coordinating Center group • Executive Committee • NIDCR staff • Protocol Review Committee • IRBs or ethics committees • DSMBs and OSOCs • NIDCR PBRN Monitoring Committee • Let’s discuss one of these PBRNs as an example …

14. DPBRN: a network about, with, and for practitioner-investigators Practical science done about, in, and for the benefit of “real world" clinical practice.

15. The DPBRN regions

16. DPBRN organization Executive Committee Protocol Review Committee NC/CC AL/MS FL/GA MN PDA SK

17. The DPBRN Executive Committee • The main decision-making body of the network • Majority voting authority lies with the six practitioner- investigator representatives

18. The DPBRN Executive Committee AL/MS Dr. Gerald Anderson Selma, AL HP/MN Dr. Pat Foy Minneapolis, MN member-at-large for combined AL/MS, FL/GA region Dr. Martha Wallace Birmingham, AL PDA Dr. Dan Pihlstrom Portland, OR SK Dr. Lotta Persson Tyringe, Sweden FL/GA Dr. Paul Benjamin Miami, FL

19. DPBRN organization Executive Committee Protocol Review Committee NC/CC AL/MS Steering Committee Regional Coordination Group FL/GA MN Study Teams PDA SK

20. DPBRN organization Executive Committee Protocol Review Committee NC/CC AL/MS Steering Committee Regional Coordination Group FL/GA MN Study Teams PDA Publications and Presentations Committee SK

21. Rules and regulations to link the practitioner-investigator to the administrative base • each practitioner must be linked to an IRB or ethics committee

22. Rules and regulations to link the practitioner-investigator to the administrative base • each practitioner must be linked to an IRB or ethics committee • this must be done for each study separately - not just once • usually done via an Individual Investigator Agreement (see OHRP at http://www.hhs.gov/ohrp/) and study- specific Practitioner Informed Consent

23. Rules and regulations to link the practitioner-investigator to the administrative base • each practitioner must be linked to an IRB or ethics committee • this must be done for each study separately - not just once • usually done via an Individual Investigator Agreement (see OHRP at http://www.hhs.gov/ohrp/) and study- specific Practitioner Informed Consent • need a mechanism to contractually obligate practitioner to administrative entity (e.g., university) and NIH rules and regulations (Memorandum of Agreement and Statement of Financial Conflict of Interest)

24. Rules and regulations to link the practitioner-investigator to the administrative base • each practitioner must be linked to an IRB or ethics committee • this must be done for each study separately - not just once • usually done via an Individual Investigator Agreement (see OHRP at http://www.hhs.gov/ohrp/) and study- specific Practitioner Informed Consent • need a mechanism to contractually obligate practitioner to administrative entity (e.g., university) and NIH rules and regulations (Memorandum of Agreement and Statement of Financial Conflict of Interest) • practitioners are remunerated for the time to do the study – not for enrolling patients into the study

25. Annual meetings of practitioners DPBRN network-wide meeting May 15-17, 2008 Intercontinental Hotel Atlanta, GA

26. Benefits as communicated by DPBRN practitioner-investigators themselves • Distinguishes the practice from other practices, acting as a practice promoter or practice builder • Increases the practice's visibility and stature among dental patients • Enhances communication with patients by showing that the practitioner-investigator cares about the scientific basis of clinical practice • Expands the vision for patient care by including a formalized research and quality improvement component to it

27. The DPBRN regions Benefits as communicated by DPBRN practitioner-investigators themselves • Receive financial remuneration for the time spent doing research • Allows practitioner-investigators to see what is effective in their practices in comparison to other practices – using results that are presented anonymously • Practitioner-investigators decide what studies are done and what treatment is done - not third parties • 8 other benefits – a ‘win-win’ for all

28. web sites of the three NIDCR-funded dental PBRNs

29. Thank you!

30. Slides from this point forward will not be presented

31. DPBRN organization Executive Committee Protocol Review Committee NC/CC AL/MS Steering Committee Regional Coordination Group FL/GA MN Study Teams PDA Publications and Presentations Committee SK