Atlanta CommunityEmory 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

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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
  Parkinsons and Alzheimer's disease
• nutritional basis to health and disease

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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

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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

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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.

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Current Training activities on the GCRCs

• 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

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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

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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

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Top 10 Funded Clinical Research Not Utilizing
GCRCs by School/Depts, 2005-2006
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Top 10 Funded Clinical Research Not Utilizing
GCRCs by School/Depts, 2006-
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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
(gt60) additional infrastructural support (n134)
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

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Specific Aim 1

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

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Specific Aim 2

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

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Specific Aim 3

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

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Specific Aim 4

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

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Proposed Clinical Interaction Sites
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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 Biomed
ical Informatics Emerging Technologies Translation
al 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
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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

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CTSA Nursing Model
Education
Flexible Resource Pool Floating
Staff RNs NT Scheduler Phlebotomist Coordinators P
ediatric Nurse Nurse Practitioner Nurse Navigator
Practice
Research
Emory Health Care CNO
Director of Clinical Interactive sites
School Of Nursing
DON
CTSA Director of Nursing
SON Curriculum
Secretarial Support

Community Outreach
Programs
Dir. of Navigators
Parish Nurse
Secretarial Support
Health Literacy
Nursing Navigators
ECLH
CHOA Egleston Scottish Rite
WCI
VA
Community Cores
EUH
Transplant Svc.
Grady
Wesley Woods
Ponce Clinic Hope Clinic
Morehouse Prevention Program
Community Clinics
Community Clinics
Community Networks
Emory Healthcare Affiliates
Nursing Homes Park Springs Retreat Center Piedmont
Pediatric Community Network
Morehouse
Faith-based Institutions
Hughes Spalding
District Community Prevention Centers
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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