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

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

Network Chair of “DPBRN” (www.DPBRN.org)Professor and Chair, Department of Diagnostic SciencesUniversity of Alabama at Birmingham School of Dentistry

“Emerging Issues in Practice-Based Research” symposium9:00 AM, Wednesday, April 1, 2009Convention Center Room D128Miami Beach, FL

Support: U.S. National Institutes of Health grants U01-DE-16746 and U01-DE-16747

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-based Community- research trials in research based

academic research settings

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

How is PBRN research different from other types of research?

CONDOR: a collaborative of three NIDCR-funded networks

DPBRN: administrative base at UABNWPRECEDENT: admin. based at UW, OHSUPEARL: 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

NIDCRNational Monitoring

Committee

CONDOR Directors Committee

CONDOR Informatics Committee

Three-Network OrganizationCONDOR 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

The DPBRN Executive Committee

AL/MSDr. Gerald AndersonSelma, AL

member-at-large forcombined AL/MS, FL/GA regionDr. Martha WallaceBirmingham, AL

FL/GADr. Paul BenjaminMiami, FL

HP/MNDr. Pat FoyMinneapolis, MN

PDADr. Dan PihlstromPortland, OR

SKDr. Lotta PerssonTyringe, 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 http://www.hhs.gov/ohrp/) and study-specific Practitioner Informed Consent

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)

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

DPBRN network-wide meeting

May 15-17, 2008Intercontinental HotelAtlanta, 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 regionsBenefits 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