Gregg H. Gilbert, DDS, MBA, FAAHD, FACD for the CONDOR Collaborative Group Network Chair of “DPBRN” ( 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 and U01-DE Developing practice-based research: a North American perspective

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

Laboratory Clinical trials Practice-basedCommunity- research trials in researchbased academicresearch settings How is PBRN research different from other types of research?

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

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

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

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

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

Geographic areas currently covered by the CONDOR PBRNs

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 Participating practitioners (n ≈ 600) after Year 04

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

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

The DPBRN regions

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

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

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

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

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

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

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 and study- specific Practitioner Informed Consenthttp://

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 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)

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 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

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

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

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 The DPBRN regions Benefits as communicated by DPBRN practitioner- investigators themselves

web sites of the three NIDCR-funded dental PBRNs

Thank you!

Slides from this point forward will not be presented

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