1. CHC Research: Innovation Built on Experience Dental PBRN Perspective Frederick A. Curro, DMD, PhD PEARL Dental PBRN Network Executive Management Team New York University / Bluestone Center for Clinical Research November 3, 2009

2. Collaboration among NIDCR (funding), NYU College of Dentistry (administrative center), and the EMMES corporation (data coordination center) Collaboration among NIDCR (funding), NYU College of Dentistry (administrative center), and the EMMES corporation (data coordination center) NYUCD Administration Center Cores – Executive Management Team NYUCD Administration Center Cores – Executive Management Team Protocol development and training – V. Thompson, DDS, PhD Protocol development and training – V. Thompson, DDS, PhD Recruitment, retention and operations – F. Curro, DMD, PhD Recruitment, retention and operations – F. Curro, DMD, PhD Information dissemination – R. Craig, DMD, PhD Information dissemination – R. Craig, DMD, PhD Organization of the PEARL Network

3. CHC Research Is it needed? Is it worth it? Is it representative? Is it “generalizable”? Is it doable? Summary: Solution may be in the term “comparative effectiveness research” as a basis for robustness of clinical translation (Society benefit)

4. CHC Research “Serious oral disorders may undermine self-image and self esteem, discourage normal social interaction, and lead to chronic stress.” (Patient + medical benefit) Dr. David Satcher, former US Surgeon General

5. CHC Research Data collection – real time recording of patient data as “standard of practice” Additional data collection – adding more data than the standard of practice Standard of care study – treatment of the patient remains as usual Comparative standard of care study Comparative effectiveness study Summary: Study design is limiting and requires thoughtful selection

6. CHC Research Not all CHC have the ability to conduct clinical research Mission statement of the CHC Clinical research could have an outcome of benefiting the CHC – improving logistics CHC operating on the “fringe” will not produce useful data Financial stability + motivation to improve Summary: Selectivity

7. CHC Research CHC are designed to see a maximum number of patients – cost effectiveness Patients are given maximum dentistry per visit Number of procedures vs. prevention vs. compliance Difficult to interrupt the patient flow with a study protocol Summary: In reality CHC logistics are against the flow for conducting clinical research - selectivity

8. CHC Research – Operations Model Office logistics Office ergonomics Personnel support Electronic data capture – direct data entry Medical/Dental/Research home Patient compliance Treatment planning Training Summary: GCP

9. CHC Research Operations Model The operations model from the CHC to the core infrastructure are connected by trained clinical research associates (CRA) who maintain a quality assurance mindset anchored in GCP

10. CHC Research Turnover of staff – professional and other Sustaining motivation of staff Sustaining patient motivation – education Shift of health care on consumer – package insert Complexity of the health care system Summary: Infrastructure

11. CHC Research Challenges from site, patient, practitioner, organization and motivation What does it take to support clinical research at the CHC level – PBRN initiative Capturing data as opposed to initiating a study User friendly EDC system Summary: Infrastructure with Coordinating Center

12. CHC Research Represents a part of the population that is included in the health care system and thus should be considered in the term “generalizability”. Studies should be designed for all phases of a clinical situation or treatment to demonstrate robustness of the treatment – best practice All socio-economic strata's should be included under the banner of “prevention for a Nation”.

15. CHC Research Feasibility – With appropriate support Data integrity – With appropriate support Strengths – Generalizability + Diversity Model : Requires an infrastructure to maintain support to be consistent with GCP to ensure data integrity of selective and highly motivated CHCs

16. CHC Research There are no simple studies - some are only more complex than others All studies require an infrastructure to support GCP Thank you for your attention The End