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4/20/2015
Facilitating Clinical Research:
The South Carolina Clinical &
Translational Research (SCTR)
Institute
Clinical and Translational
Science Award
What is it ?
Karen E. Packard, MSN, RN, AOCN, CCRP
Nurse Manager III/Administrator
Research Nexus
May 2, 2015
http//sctr.musc.edu
843-792-8300
Clinical and Translational
Science Award
CTSA support:
• Enables collaboration for common problems
• Accelerates lab discoveries into new treatments for patients
• Trains the next generation of researchers
• Engages communities in clinical research
http//sctr.musc.edu
843-792-8300
Title of Slide
• The CTSA Program is designed to
strengthen and support the entire
spectrum of translational research from
scientific discovery to improved patient
care
http//sctr.musc.edu
843-792-8300
Funding Agency
National Center for Advancing
Translational Sciences (NCATS)
• National Institutes of Health
• Transform and accelerate the translational
research process
• Does not concentrate on specific diseases
• 62 CTSA-funded institutions
http//sctr.musc.edu
843-792-8300
South Carolina Clinical &
Translational Research Institute
• First Awarded-2009
Content
• Content
• $20,000,000/5 years
• New application submitted 1/2015
http//sctr.musc.edu
843-792-8300
http//sctr.musc.edu
843-792-8300
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4/20/2015
The “Front Door” to
SCTR services
SUCCESS Center SCTR’s Front Door
Free Consultations and Research Training:
Regulatory Consults Research Navigation
Research Toolkit
(includes IACUC, IBC, IND/IDE)
Recruitment
SCresearch.org
eIRB Statewide PM REDCap Consults
Grants & Contracts
Budget Development
Consults
SUCCESS CENTER
• 800 consultations/yr
• 4,000 uses/yr Research Toolkit
• 4,387 REDCap projects
• 7,085 SPARC Requests
– In use at 6 other CTSAs
– 19 institutions in demo phase
MAP‐R
Epic Research Team
SPARC Request
Study Tracker
South Carolina Clinical &
Translational Research Institute
Pilot Projects
SCTR supports the conduct of pilot projects in
grant categories:
• Discovery
• Early career Investigator
• Novel Methodology and Technology
http//sctr.musc.edu
843-792-8300
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4/20/2015
Pilot Project Program
11 Scientific Retreats: 1,100 attendees statewide
110 Pilot Projects Funded
ROI 10 to 1 ($32.6M)
21 patent/IP disclosures
42 extramural awards
24 awarded to Early Career investigators (22%)
5 co‐funded the HSSC to use the Clinical Data Warehouse
7 other MUSC Programs using SCTR Pilot Project Software: 3 COBREs, Global Health, Genomics, Telehealth, Lupus Research
125 Vouchers: associated with $14.9M in funding
http//sctr.musc.edu
843-792-8300
Community Engagement
Biostatistics
• Provide methodological expertise to translational researchers
• Collaboration
• Research design
• Communication and
dissemination
• Social/cultural advisors
• Community site training
• Stimulate methodological development in the areas of study design and
biostatistics
• Examples of requests
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




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Sample size / power estimation
Analyses of preliminary data for a grant
Development of analysis plans
Assistance with manuscript preparation
Grant review
Survey design
1 on 1 didactic teaching
4th Cohort of the Community-Engaged Scholars Program, 2013
http//sctr.musc.edu
843-792-8300
Biomedical Informatics
http//sctr.musc.edu
843-792-8300
INFORMATICS STRENGTHS
Provides investigators with access to:
• Software tools
• Databases
• Support systems
REDCap, CDW, SPARC Request , Research
Toolkit, MUSC approval Plans for Research
tool (MAP-R),eIRB, Palmetto Profiles,
Scresearch.org
http//sctr.musc.edu
843-792-8300
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4/20/2015
Clinical Data Warehouse (CDW)
REDCap
• https://sctr.musc.edu/index.php/research-tools/redcap
MUSC electronic clinical data
•
•
OACIS and Epic clinical data repository
Patient demographics, ICD-coded diagnoses, CPT-coded procedures, and
laboratory test results
CDW Data request committee
•
•
•
Review the clinical data needs of your research project
Provide advice on requesting IRB approval to obtain clinical data from the
CDW
Discuss options for clinical data abstraction, reporting and storage to meet
your research needs
• Secure, web-based data capture application for research studies
• Intuitive interface for data entry (with data validation)
• Audit trails for tracking data manipulation
• Automated export for data downloads to common statistical packages
• Other features include:
•
branching logic
•
calculated fields
•
data de-identification
•
survey capabilities
• Free consultations to guide you in database/survey development
http//sctr.musc.edu
843-792-8300
http//sctr.musc.edu
843-792-8300
Search and Find Research Services and Resources for your Proposal in One Easy to Use Location
 SPARC Request is a web‐based research management system
 Research service and resource catalog
 Provider/core facility service request management system
 Investigator Dashboard
 Administrative Portal
Focus on one stop shop research service catalog and request, budget development and billing compliance, audits, and reporting
© 2011, 2012, 2013, 2014 Medical University of South Carolina.
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4/20/2015
SCTR Research Nexus Fee Based
Research Support
•
Research Opportunities & Collaborations
•
Research Coordination and Management
•
Research Laboratory and Biorepository
•
Research Center
•
Body Composition and Pulmonary
Research Opportunities &
Collaborations
•
Identify industry-funded clinical trials
•
Sponsor and Contract Research Organization (CRO) outreach
•
Pair trial opportunities with MUSC Investigators
•
Assistance navigating the site selection process
Function Testing
•
Clinical Nursing and Nutrition
Research Opportunities & Collaborations program manager, Signe Denmark, and Quintiles Site Relationship Manager, Kelsey Morgan.
Contact Signe at 843.792.4146 or [email protected]
http//sctr.musc.edu
843-792-8300
http//sctr.musc.edu
843-792-8300
Research Opportunities &
Collaborations
Research Coordination and
Management
• 282 Industry Contacts – 283 MUSC PI Contacts (Oct. 2012 – Oct. 2014)
• 48 Fully Executed Contracts: total award amount $14.5M
• 12 Trials in CTA/Budget negotiations $2.7M
•
Trained and experienced research and nurse coordinators
•
Services include:
• Study coordination
• Project coordination
• Regulatory management
• Data management
• Quintiles Partnership Success Metrics
• MUSC GCP and Quality Metric is 97.6% • Average enrollment factor 181% • Enrolls More 129% and Enrolls Faster 133% compared to other academic medical centers
• Recruitment
• Budget development
• Study record and drug storage
• Quality assurance reviews
•
Available for full, partial, or gap support
•
Inpatient, outpatient, and outlying clinics
http//sctr.musc.edu
843-792-8300
http//sctr.musc.edu
843-792-8300
Research Laboratory
RCM Usage
OB/GYN, 3
Dermatology, 1
IOP, 3
Pulmonology, 4
IRB, 1
OB/GYN
VA, 1
Dermatology
Cardiology, 10
IOP
College of Nursing, 2
IRB
VA
Rheumatology, 5
Radiology
Neurosciences
Radiology, 24
Family Medicine
Surgery, 7
•
•
•
•
•
Processes biological specimens
Packaging and shipping to Central Laboratories
Nucleic acid extraction
ELISA protocols
Develop/customize protocols
Orthopedic Surgery
College of Health Professions
Hematology/Oncology, 3
Internal Medicine
Nephrology, 2
SCTR
Neurosciences, 3
Family Medicine, 3
Pediatrics
Hollings
Nephrology
Hollings, 22
Orthopedic Surgery, 5
Hematology/Oncology
Surgery
Internal Medicine, 11
Pediatrics, 4
SCTR, 2
College of Health Professions, 3
Rheumatology
College of Nursing
Pulmonology
Cardiology
http//sctr.musc.edu
843-792-8300
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4/20/2015
Research Nexus Clinic and Lab Use By Number of Protocols
Research Center
HCC‐Oncology *
1
1
1
1
2
2
Pulmonary
2 11
Psychiatry
Rheumatology
2
25
3
1
Pediatrics
2
Endocrinology
2
8 examination rooms and 3 procedure rooms
Surgery
Internal Medicine
1
Neurology
2
Radiation
3
Pediatric Cardiology
Neonatology
4
18
Radiology
Dermatology
8
Nephrology
6
Gastroenterology
OBGyn
Infectious Disease
Pulmonary Function Testing (PFT) suite
College of Nursing
Body composition suite with BodPod and Hologic Discovery A
Dexascan
College of Health Professions
Note: 89 Studies: Clinic and Lab used by 5 of the 6 MUSC Colleges‐FY 14
*Majority are lab only
College of Graduate Studies
College of Dental Medicine
http//sctr.musc.edu
843-792-8300
Clinical Nursing and Nutrition
•
Clinical Nursing services include:
• Conduct study protocol procedures
• Secure specimens
• Administer medication
• Gather critical data at bedside
• SOC nursing support, as needed
• Mobile nursing
•
Nutrition services include:
• Collect and assess macro and micro nutrient intake
• Provide nutrition education in individual or group sessions
• Coordinate nutrient specific meals and/or snacks
Education and Training
TL1 program – predoctoral research training across disciplines/colleges Developed KL2 program – 10 scholars completed, all have extramural funding
Coordinated activities in K programs across campus
Created
K to R club
SOCRATES
Grant Writing Course
Annual mentorship Symposium
http//sctr.musc.edu
843-792-8300
Education and Training Coordinated Pipeline from Secondary ‐ Faculty
http//sctr.musc.edu
843-792-8300
Funding Opportunities
• Pilot Projects
• Community Engaged Scholars
• Vouchers
• External Research Funding
Opportunities
• TL1 Awards
• KL2 Awards
http//sctr.musc.edu
843-792-8300
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4/20/2015
New Initiatives 2015‐2019
• EPIC research functionality
• Recruitment
New Initiatives
• Team Science training/funding/promotion criteria
• Enhanced stakeholder engagement
• Questionnaires through MyChart
• Participant engagement
• Broadly defined – legislators, advocacy groups
• bidirectional communication • Therapeutic translation program
• Living Biobank
• Gap funding
• Research Metric tracking through SPARC
• Training/consultation
• Monitor time to approval/contracting/etcl
• Health Technology Solutions
• Monitor participant accrual
• Multi‐site Study Consultation/Support
http//sctr.musc.edu
843-792-8300
Tech Transfer Activity Since SCTR Co‐funded: Technology Development Officer (TDO)
http//sctr.musc.edu
843-792-8300
SCTR By the Numbers
By The Numbers (2009‐2014)
• # of invention consults went from 0 to 100+ per year
• # of disclosures more‐than doubled
• # of patent applications doubled
http//sctr.musc.edu
843-792-8300
• $400M+ in Economic Impact
• 7,500+ consultations/requests
• 16,000+ patients enrolled in clinical trials
• 1,100 scientific retreat attendees
• 41 Pre‐ and Post‐doctoral Scholars funded
• 2 Institute of Medicine accolades for Community Engagement
http//sctr.musc.edu
843-792-8300
Questions?
[email protected]
792‐8300
http://sctr.musc.edu
http//sctr.musc.edu
843-792-8300
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