Atlanta Community/Emory CTS Application

1. Atlanta Community/Emory CTS Application Patient and Clinical Interaction Resources

2. Background-Planning Grant Overarching Aim • Creation of a transforming plan for clinical and translational research at Emory University and the WHSC

3. CTSA Planning Proposal Specific Aim 1: Assess the infrastructure, design and limitations of interdisciplinary clinical and translational research as a discipline at Emory. Specific Aim 2: Determine how the CTSA will impact the quality of clinical and translational science at Emory (e.g. what are the essential participant, clinical resources and facilities).

4. Emory GCRC • Emory GCRC began funding in 1960 • Directed by Dr. Thomas Ziegler • A discreet outpatient and per diem inpatient (11 room) unit • 11,789 sq. ft. with a core laboratory (1668 sq. ft.), bionutrition unit (555 sq. ft.), bioinformatics area (478 sq. ft.) and administration area (1932 sq. ft.) • 113 clinical investigators and 117 approved protocols

5. Investigative focus at the Emory GCRC • rare genetic and inborn errors of metabolism • hypertension, cardiovascular disease, obesity, insulin resistance, diabetes • pharmacokinetics and drug metabolism • transplantation • regenerative medicine • endothelial biology • inherited renal disorders and glomerulonephritis, • sleep disorders • pregnancy-related disorders and pharmacology • neurological disease registries • neurobiology and the treatment of affective disorders • neurodegenerative disorders including Parkinson’s and Alzheimer's disease • nutritional basis to health and disease

6. Grady Satellite GCRC • Grady satellite GCRC initiated funding and began its first study in 2002 • discreet outpatient and per diem inpatient (2 room, 4 bed) unit • 4800 sq. ft. and includes a processing laboratory (307 sq. ft.) coordinator area (307 sq. ft.) and administrative area (289 sq. ft.). • There are 39 clinical investigators with 58 approved protocols

7. Grady Satellite GCRC • Directed by Dr. Guillermo Umpierrez • Committed to collaborative studies performed between Morehouse and Emory investigators • recruitment of Grady employees as research participants • recruiting Grady patients for participation in clinical studies

8. Investigative focus at the Grady Satellite GCRC • HIV-related illnesses • health disparities of risk for cardiovascular disease and myocardial infarction (Morehouse-Emory partnership) • depression • participant partnering in clinical research • health literacy • family planning and interpregnancy care • blunt head trauma • sickle cell disease (Morehouse and Emory investigators) • hypertension, obesity, hyperlipidemia, insulin resistance, diabetes • alcohol-related lung injury, • secondary prevention of stroke and other neurological disorders.

9. Current Training activities on the GCRC’s • 2 week curriculum of the K30 students • Educational rotations for the MD/PhD students • 6 K12 awardees currently utilize the GCRC and have 7 active research protocols

10. GCRC Supported Research 2005 • Research Unit Research Support (%) • Emory GCRC $20,933,098 16 • Grady GCRC $5,058,797 4 • GCRCs $25,991,895 20 • Emory Univ $126,477,425  100

11. GCRC Supported Research – 2006 to date Research Unit Research Support (%) Emory GCRC $10,261,815 15 Grady GCRC $2,873,534 4 GCRCs $13,135,349 19 Emory Univ $67,986,377 100

12. Top 10 Funded Clinical Research Not Utilizing GCRC’s by School/Depts, 2005-2006

13. Top 10 Funded Clinical Research Not Utilizing GCRC’s by School/Depts, 2006-

14. Survey regarding infrastructure needs • Protocol development, execution, coordination • Specimen collection, transportation, processing, assays • Subject education and questionnaire administration • Biostatistic/bioinformatic support • Nutritional assessments and support • Recruitment, scheduling, consenting • Adverse event reporting

15. Areas where investigators strongly recommend (>60%) additional infrastructural support (n=134)

16. Frequency (%) of GCRC and non-GCRC investigators who strongly need the GCRC or alternate sites for clinical investigation

17. Identified Barriers to the Conduct of Clinical and Translational Research • Complexity and lack of support during initial protocol development, submission, review and implementation process • Lack of diversified support from well trained research staff (scheduling, recruitment, consenting, protocol conduct, sample handling) • Restriction of physical locations for the conduct of clinical investigation • Lack of communication between disciplines and investigative teams

18. Specific Aim 1 To provide flexible clinical interaction resources for the conduct clinical and translational research

19. Specific Aim 2 To improve availability, environment and support for the conduct of the highest quality and ethical clinical and translational research

20. Specific Aim 3 To increase access to and for community-based research participants in clinical and translational research programs

21. Specific Aim 4 To provide a high quality environment for training and career development in clinical and translational research

22. Proposed Clinical Interaction Sites WW PCIS AVAMC PCIS Emory PCIS Hope PCIS Ponce PCIS CLH PCIS Grady PCIS

23. CTSA Protocols CTSA Steering Committee Chair – Arlene Chapman Scientific Advisory Group Chair – Tom Pearson 1/2 expedited 1/2 full review • Research Support Office – • RSA DSMB/DSMP • Compliance Office • Regulatory Support Office • Grant and manuscript preparation • Administrative Reviews • Continuing Research Education Program Services Clinical Interaction Sites Community Engagement Health Disparities Education and Training Pilot, Feasibility, and Innovation Program Design and Biostatistics Biomedical Informatics Emerging Technologies Translational Core Nurse Navigator/Protocol Facilitator EU IRB Principal Investigator Protocol Submission Web Portal n ≈ 200/year Human Subject Protocols K12, K30, K08, K23 Pilot & Feasibility/Seed Projects Available for Pre-submission grant applications and investigators desiring CTSA support

24. Potential Prioritization for Protocol and CTSC Resource Approval • Scientific quality and potential impact/publication • Pilot and Feasibility programs • Studies involving investigators from two or more partnering institutions • Involvement of minority populations • Health disparities focus • Existing funding support • Number of trainees utilizing clinical interaction sites

25. CTSA Nursing Model Education Flexible Resource Pool Floating Staff RNs NT Scheduler Phlebotomist Coordinators Pediatric Nurse Nurse Practitioner Nurse Navigator Practice Research Emory Health Care CNO School Of Nursing Director of Clinical Interactive sites DON CTSA Director of Nursing SON Curriculum Secretarial Support Community Outreach Programs Dir. of Navigators Parish Nurse Secretarial Support Health Literacy Nursing Navigators Community Cores VA ECLH Grady CHOA Egleston Scottish Rite EUH Transplant Svc. Wesley Woods WCI Ponce Clinic Hope Clinic Morehouse Prevention Program Community Clinics Community Networks Community Clinics Morehouse Pediatric Community Network Emory Healthcare Affiliates Nursing Homes Park Springs Retreat Center Piedmont Faith-based Institutions Hughes Spalding District Community Prevention Centers

26. Webportal / E-protocol Submission • Pre-Scientific Review: • Administrative, biostatistical, design, ethics, technology review and approval • translational and emerging technology core impact factor • research support IRB/DSMB/DSMP/Compliance preparation IRB Review & Approval Scientific Review & Approval Pre-Protocol Initiation: Community outreach: recruitment, advertising, protocol education Tech: sample handling protocols CR-Assist – web-based scheduling CIS – day-to-day protocols, CRF development, nurse/lab training Protocol Initiation CO: recruitment milestones, advertising, ongoing subject education BIOSTATS: data integrity triage TECH: assay completion CIS: protocol deviations, sample acquisition, success rates, subject satisfaction, safety Protocol Completion CO: disseminate results, physician/patient education, feedback on surveys BIOSTATS/BIOINF: data analysis TECH: Assay completion RSO: Manuscript preparation Translational/Emerging: Results analysis impact