Atlanta Community/Emory CTS Application

Patient and Clinical Interaction Resources

Background-Planning Grant Overarching Aim

• Creation of a transforming plan for clinical and translational research at Emory University and the WHSC

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).

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

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

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

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

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.

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

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

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

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

2006School/Dept Total Percent

School of Public Health - Beh. Science & Health Ed $9,032,612.00 8.7

School of Medicine - Infectious Diseases $7,769,560.00 7.5

School of Medicine - Psychiatry $7,615,906.34 7.3

School of Public Health - Epidemiology $7,212,183.00 6.9

School of Medicine - Winship Cancer Institute $5,242,675.00 5.0

School of Medicine - Pathology $5,038,938.00 4.9

School of Medicine - Microbiology $4,647,038.00 4.5

School of Medicine - Genetics $4,215,279.00 4.1

School of Public Health - Environ & Occupational Health $4,130,382.00 3.9

School of Medicine - Biomedical Engineering $4,086,127.00 3.9

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

School/Dept Total Percent

School of Medicine - Infectious Diseases $5,793,597.00 10.0

School of Medicine - Winship Cancer Institute $5,204,316.00 8.9

School of Medicine - Psychiatry $5,021,505.00 8.6

School of Medicine - Microbiology $5,017,183.00 8.6

School of Public Health - Beh. Science & Health Ed $4,288,095.00 7.4

School of Medicine - Pathology $3,360,497.00 5.8

School of Public Health - Health Policy/Management $2,744,071.00 4.7

School of Medicine - Surgery $2,559,873.00 4.4

School of Medicine - Genetics $2,324,214.00 4.0

Yerkes - Vaccine Research Center $2,058,949.00 3.5

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

Areas where investigators strongly recommend (>60%) additional infrastructural support

(n=134) Protocol development, execution, coordination

3

Specimen collection, transportation, processing, assays

1

Subject education and questionnaire administration

5

Biostatistic/bioinformatic support 4

Nutritional assessments and support 7

Recruitment, scheduling, consenting 2

Adverse event reporting 6

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

clinical investigation

0

10

20

30

40

50

60

GCRC Alt sites

GCRC invest

Non-GCRC invest

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

Specific Aim 1

To provide flexible clinical interaction resources for the conduct clinical and translational research

Specific Aim 2

To improve availability, environment and support for the conduct of the highest quality and ethical clinical and translational research

Specific Aim 3

To increase access to and for community-based research participants in clinical and translational research programs

Specific Aim 4

To provide a high quality environment for training and career development in clinical and translational research

Proposed Clinical Interaction Sites

Grady PCIS

CLHPCIS

AVAMCPCIS

WWPCIS

EmoryPCIS

PoncePCIS

HopePCIS

CTSA Protocols

Research Support Office – RSA DSMB/DSMP

Compliance OfficeRegulatory Support OfficeGrant and manuscript preparationAdministrative ReviewsContinuing Research Education

CTSA Steering Committee

Chair – Arlene Chapman

Scientific Advisory GroupChair – Tom Pearson

1/2 expedited1/2 full review

Nurse Navigator/Protocol

Facilitator

EU IRB Principal InvestigatorProtocol Submission

Web Portal n ≈ 200/year

Human Subject ProtocolsK12, K30, K08, K23Pilot & Feasibility/Seed ProjectsAvailable for Pre-submission grant applications and investigators desiring CTSA support

Program ServicesClinical Interaction SitesCommunity Engagement

Health Disparities Education and Training

Pilot, Feasibility, and Innovation ProgramDesign and BiostatisticsBiomedical InformaticsEmerging Technologies

Translational Core

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

Director of Clinical Interactive sites

School Of NursingEmory Health CareCNO

CTSA Director of Nursing

Dir. of Navigators Programs

Ponce Clinic Hope Clinic

ECLH CHOAEglestonScottish Rite

WCI

Secretarial Support

Secretarial Support

Practice Education Research

DON

Community Outreach

Health Literacy

Parish Nurse

Flexible Resource PoolFloating StaffRNsNTSchedulerPhlebotomistCoordinatorsPediatric NurseNurse PractitionerNurse Navigator

Nursing Navigators

CTSA Nursing Model

VA

SON Curriculum

Community Cores

Community Clinics

Community Clinics

EUH Transplant Svc.

Emory Healthcare Affiliates

Grady Wesley Woods

Nursing HomesPark Springs Retreat Center

Piedmont

Pediatric Community Network

Hughes Spalding

Morehouse Prevention Program

Community Networks

Faith-basedInstitutions

DistrictCommunity

Prevention Centers

Morehouse

Pre-Scientific Review:1Administrative, biostatistical, design, ethics, technology review and approval2translational and emerging technology core impact factor3research support IRB/DSMB/DSMP/Compliance preparation

Webportal / E-protocol Submission

CO: recruitment milestones, advertising, ongoing subject educationBIOSTATS: data integrity triageTECH: assay completionCIS: protocol deviations, sample acquisition, success rates, subject satisfaction, safety

Pre-Protocol Initiation:Community outreach: recruitment, advertising, protocol educationTech: sample handling protocolsCR-Assist – web-based schedulingCIS – day-to-day protocols, CRF development, nurse/lab training

IRB Review & ApprovalScientific Review & Approval

Protocol Initiation

Protocol Completion

CO: disseminate results, physician/patient education, feedback on surveysBIOSTATS/BIOINF: data analysisTECH: Assay completionRSO: Manuscript preparationTranslational/Emerging: Results analysis impact