Yale Center for Clinical Investigation:
From the lab, to the clinic to the community
Brown Bag Luncheon Series: Presentation
Tesheia H. Johnson, MBA, MHS
Wednesday, April 22
12:00pm
The Anlyan Center (TAC)
N107 auditorium
The Problems
Facing Clinical
Research at Yale in 2004
• Lack of comprehensive
training for fellows and
faculty
• Lack of appropriate
infrastructure to facilitate
clinical and translational
studies
Strategic Plan Recommendations from the Clinical
and Population-Based Research Committee
• Create a centralized structure to support clinical and
population-based research
• Improve information systems to support data collection,
training, and processes of clinical research
• Integrate institutional expertise in clinical care, clinical
research, and basic research in an ongoing planning process
• Develop metrics to refine and plan institutional efforts in
clinical and population-based research
The Solution: The Development of the
Yale Center for Clinical Investigation (YCCI)
Programmatic Goals
1.
To develop the next generation of clinical scientists by
attracting talented pre- and post-doctoral students and junior
faculty members across multiple disciplines; training them in
the use of state-of-the-art research tools; giving them the
skills to work within complex research teams; and supporting
their professional development.
2.
To foster the translation of disease-related discoveries from
the laboratory into the clinic and then into the community, in
a variety of ways:
•
By stimulating the creation of interdisciplinary
teams of translational researchers
•
By establishing an organizational and regulatory
infrastructure to support clinical studies
YCCI History and Timeline
Structure and Governance of YCCI
How is YCCI Supported?
• Clinical and Translational Science Award (CTSA)
funded by NCRR
• Institutional Support
• Fee for services charges to Investigator grants
The CTSA
(Direct & Indirect Costs)
$57.3 M
- $2.8 M
- $10 M
$60,000,000
$50,000,000
$40,000,000
$30,000,000
$20,000,000
$10,000,000
$CTSA as Originally
Awarded
Revised Total Award
w/ Current Cuts
Renewal Capped
Award
Institutional Commitment to YCCI and
Related Programs
From CTSA award through FY 09
$15.1M
$15.9M
$15.4M
$16,000,000
$14,000,000
$12,000,000
$10,000,000
$8,000,000
$6,000,000
$4,000,000
$2,000,000
$2007
2008
YCCI Adminstration
YCCI & YCC Research Services
Faculty Programs Promoting Diversity
Research Cores
2009
Educational Programs & Scholars
Total Value of all NIH Research
Connected to the Yale CTSA
(Researcher Utilizing Services, Scholars, and Mentors)
9 months
$157,435,688
8 months
$160,000,000
$124,300,594
$140,000,000
$120,000,000
$97,083,051
$100,000,000
$80,000,000
$60,000,000
$40,000,000
$20,000,000
$Grant Year 1
Grant Year 2
Grant Year 3 (to date)
Components of YCCI
• Research Education, Training and Career Development
• Faculty
• Staff
• Office of Research Services, including Regulatory and
Clinical Research Support and Space
• Pilot Studies Program
• Research Cores
• Informatics
• Biostats and Study Design
• Community Engagement
Opportunities to obtain support / funding
from YCCI?
• Scholar Awards
• Annual competition for any faculty member in first 5 years of appointment
• Up to 75% salary support and up to $30K for supplies
• 2 year award
• Pilot Grants
• Past open calls for proposals and awards have included:
• Translational and Interdisciplinary Research Teams (up to $75K/yr for 2
years)
• Development of Novel Methodologies (up to $25K/yr for 1 year)
• Core Utilization Pilot (up to $15K/yr for 1 year)
• Community-based Research Partnerships (up to $25K/yr for 1 year)
• Jr. Faculty Pilot (up to $25K/yr for 2 years)
• Office of Research Services
YCCI:
Educational Programs
A Comprehensive Training Program for the Next
Generation of Clinical and Translational Scientists
• The Scholars and Mentors are the Educational Centerpiece of YCCI
Leadership Team
• Judy Cho, MD, Co-Director for Education
(YCCI Scholar Program, Career Development—Translational Research)
• Eugene Shapiro, MD, Co-Director for Education,
Director of KL-2 Program & Deputy Director
Investigative Medicine Program
(YCCI Scholar Program, Career Development, KL-2 Program, IMP
Program and Teaching and Integration of all Programs—Clinical
Research)
• Joseph Craft, MD, Director of Investigative Medicine
Program
• John Forrest, Jr., MD, T32 Program Director
(focus on T32 Program Development & Training Program Integration)
YCCI Programmatic Goals
•
•
To develop a cadre of outstanding
researchers in patient-oriented research,
and to prepare them to assume leadership
roles in academia.
To foster the translation of disease-related
discoveries from the laboratory to the clinic
and then into the community, in a variety of
ways:
YCCI Educational Programs
• K Scholars
• YCCI Scholars
• Investigative Medicine Program Trainees
• T32 Trainees
YCCI Scholars
Junior faculty supported by K Awards or the CTSA
Clinically trained physicians seeking PhD
Junior faculty or Graduate PhD candidates
in nursing, EPH, and Biomedical engineering
T32 – Medical, nursing, EPH, and Biomedical
engineering seeking a Masters degree
YCCI Scholars
Grant Year 1
Number of
Trainees
Grant Year 2
Number of
Trainees
Grant Year 3
Number of
Trainees
YCCI Faculty Scholars
K Scholars
IMP Trainees
T32 Trainees
T32 Trainees -Short-term
15
5
10
9
9
19
6
14
9
8
13
3
18
9
8
Total
48
56
51
Program
Program Funding
CTSA Grant Total
YSM
$
$
Total All Programs
$
1,591,928 $
1,416,000 $
3,007,928
$
2,730,746 $
1,535,000 $
4,265,746
Does not include 9 pending awards – April 1, 2009
$
3,125,531
2,285,000
5,410,531
YCCI Scholars
Diverse Departmental & School Representation
Neurobiology
3%
Diagnostic Radiology
6%
Child Study Center
3%
Pharmacology
3%
Psychiatry
18%
Laboratory Medicine
3%
School of Nursing
6%
School of Public Health
9%
Medicine represents 6
different sub-specialties
Medicine
34%
Pediatrics
12%
Obstetrics and
Gynecology
3%
~ $16.9 Million in Independent Funding
by Category for YCCI Scholars
Career
Development Industry
Sponsored
1%
Career
Development- NIH
K
33%
Career
Development Research
Foundation
5%
Clinical Trial Industry
Sponsored
1%
Research Grant Industry
Sponsored
Research Grant 1%
Foundation
7%
Clinical TrialInvestigator
Initiated
5%
Research Grants All Other NIH and
Federal
47%
New Initiative: Society of YCCI Faculty
Mentors for the Training of
YCCI Junior Faculty Scholars
• Faculty members chosen based on the quality of their
clinical and translational research and their track records
in mentoring young scientists.
• Each YCCI scholar will have an advisory committee
consisting of 2- 3 faculty mentors from this group that cover
diverse disciplines related to the scholar’s project.
• Provision of a small amount research support for
participation in the program.
• 100% Acceptance of Invitations to Participate!
Investigative Medicine
Program (IMP)
• The Investigative Medicine Program is a unique training
program that leads to a Ph.D. degree in Investigative
Medicine.
• Students undertake thesis work in a variety of
disciplines. These include:
• Evaluating risk factors and interventions for disease
using modern concepts in quantitative methods and
clinical study design.
• Exploring the molecular basis for a disease from the
laboratory standpoint.
• Investigating the biochemical, physiologic and genetic
basis for disease in the setting of a Clinical Research
Center.
T32 Program
• Program Goal
• To establish a flexible educational program to
expand clinical/translational training among
predoctoral medical, nursing, M.D./Ph.D. and
biomedical engineering students
• In first two years of the CTSA education
component, 18 students have been funded.
Master’s Program
• Masters Program Overseen By YCCI
Co-Directors of Research and
Yale School of Medicine Office of
Education
Master’s Program
• Courses include
•
•
•
•
Epidemiology
Biostatistics
Drug design (bench to bedside)
Practical and Ethical Issues in
Clinical/Translational Research
• Electives
New Program
• Yale Pediatric Faculty Scholar’s
Program
• Goal: To encourage innovative research and
collaboration among faculty who do NOT
necessarily have 75% protected time for
research
YCCI:
Office of Research Services
(ORS) and the Clinical
Research Units, including
“former GCRC”)
Mission of ORS
• Enhancing and integrating the resources
that support the timely development of the
highest quality clinical and translational
research studies
• Providing a safe and efficient environment
for the implementation and completion of
clinical and translational research studies
ORS: Increases in Services and Staff
One-stop Shopping
Services
Then (GCRC)
Now (ORS)
Biostatitical Support
Education / Quality Assurance
Informatics
Financial Management
Patient Recruitment
Budget Development
Protocol Development
Research Nursing and Assistants
Study Coordination
1
0
2
1
0
0
0
13
0
5
1.5
4
3
2
2.5
3
16
14
Total FTEs
17
51
Our Progress: Improvements in the
Research Timeline
Number of
Protocols
Average Days from
YCCI intake to IRB
Submission
Average Days from
IRB Submission to
IRB approval
Combine Average
Days from YCCI
Review to IRB
Approval
Year 2
108
40
40
80
Year 3 *
118
23
22
45
10
-17
-18
-35
Grant Year
Difference Grant
Year 2 to 3
•
These improvements are due to major changes in the review process, the addition of
staff trained regulatory staff working with the investigator to prepare better
submissions, and the start of the implementation of the new Coeus IRB electronic
system for protocol approvals.
•
In the past year the averages days to approval has been reduced by 35 days.
•
Since CTSA award ORS has gone for 51 protocols to the current 118 utilizing its
services.
•
* Year 3 Data, excluded one investigator who took 165 days to respond to changes required for submission.
Participant & Clinical Interaction
Resource (PCIR)
Components at Yale
• Hospital Research Unit (HRU) former
GCRC Unit
• New research unit at 2 Church Street
South
Office of Research Services (ORS)
at 2 Church Street South
In-patient
Unit
Office of Research Services (ORS)
Clinical Facilities
YNHH 10-6 and 2 Church Street So
These facility includes:
• Examining rooms (Inpatient and outpatient)
• Office space for clinical research personnel (e.g. RN and APRN
nurse coordinators, patient care associates, research assistants
conducting studies on site)
• Reception area & waiting room for research subjects & families
• Phlebotomy and blood processing facility
• Freezers and refrigerators
• Storage space
• Conference Rooms
YNHH Clinical Research Unit
(former GCRC)
ORS Aim 2: Acquire, Renovate and Equip
ORS and PCIR space @ Church St.
Exam Room
Conference Room
Education &
Training New
Research Staff
Exam Room
Protocol Development
Church Street Clinical Research Unit
(Minimal Risk Outpatient Studies)
This facility includes:
• 6 Examining rooms
• Office space for clinical research personnel,
• Waiting room for research subjects and families,
• Phlebotomy and blood processing facility,
• Freezers and refrigerators
• Storage space
Recruitment Campaign
Help Develop the Medicine of Tomorrow
http://www.yaletrials.org/
Recruitment Campaign
300 people at the fair requesting
additional information regarding
participation
YCCI:
Pilot Grant Programs
Pilot & Collaborative Translational
and Clinical Studies Funding: 2 Yrs
Award Category
Number of
Awards
Translational & Interdisciplinary Pilot Program
Novel Clinical and Translational Methodologies Pilot Program
Core Technologies Pilot Projects
Community Engagement Partnership Pilot Projects
Cancer Center Collaborative Pilot Project
Novel Methodologies in Biostatistics and Informatics Pilot Program
Junior Faculty Pilot Program
Total
Committee will be formed to review pilot progress
6
6
4
4
1
1
3
25
Total
Awarded
$
$
$
$
$
$
$
899,925
120,359
53,303
100,000
25,000
25,000
150,000
$ 1,373,587
Pilot and Collaborative Translational and
Clinical Studies Funding
Departments Represented
Cancer Center
8% Child Study Center
4%
Surgery
8%
School of Public
Health
12%
Obstetrics and
Gynecology
4%
Psychiatry
8%
Internal Medicine
28%
Pediatrics
12%
Pathology
4%
Orthopedics &
Rehabilitation
4%
Neurosurgery
8%
YCCI:
Research Cores
Technology Core Clusters
• Imaging
• Genomics and Proteomics
• Human Specimen Analysis and Immune
Monitoring
Developing
• Physiology and Metabolism
• Cognition and Behavior
• Drug Development
Year 1 Strategic Investments in Cores
Research Core
Equipment Purchased
Developmental Electro-Physiology Lab
Portable dense array encephalography
Immune Monitoring Lab
Equipment for production of human MHC
tetramers
Keck Biotechnology Lab
UPLC system for phosphopeptide analysis
Sequenom system for SNP genotyping
QTrap mass spectrometer
MR Center
Upgrade of 4T MR spectroscopy system
PET Center
Enhancement of computer cluster
LC/MS analysis system
$1.4 Million
Efforts to Increase Core Utilization
• Developed websites and
scheduling programs
• Newsletter
• Core pilots program
launched
• Expansion of PET Center
capacity
YCCI:
Biostats and Study
Design
The Biostatistics & Study Design Core:
Programmatic Goals
• Provide Biostatistical Support Services and
Methodological Expertise to investigators and YCCI
Scholars in the design and execution of clinical and
translational research
• The teaching of biostatistics and study design to
students, fellows, and junior faculty members.
Vision for the Biostatistics & Study Design Core:
1.
To be the link between YSPH research expertise and Yale
investigators.
2.
To become a hub for integration of Biostatical support on the
Health Sciences Campus.
3.
Develop a plan with EPH to assist in the development
of an epi-genetics program focused on a specific disease.
4.
The areas CTSA considers most critical for the new Director
to develop:
Data coordinating center for clinical trials
Genomics
YCCI:
Informatics
Biomedical Informatics Core
Research Support and programmatic goals:
• Web-accessible databases for collection of
research data (Trial DB)
•Specimen/study tracking system
(LIMS, nearly completed)
•Institutional clinical data repository
(Programmatic goal)
Biorepository Progress
Kevan Herold, M.D., YCCI Biorepository Director
•
Biorepository Committee established. Repository will be used for storage
of tissue, peripheral blood cells, DNA, and serum from patients.
•
IRB approved protocol for storage of samples by Yale investigators
•
Jr. Faculty search underway with jointly with Department of Laboratory
Medicine
•
caTISSUE (centralized tissue-banking tool) - Michael Krauthammer,
M.D., Ph.D. awarded $175,000 NCI contract to contribute to the ongoing
caTISSUE development. Software allows flexible clinical and genomic
annotations, and multi-site banking. Yale is sharing the content of
caTISSUE on caGRID, making Yale part of the overall caBIG effort to
accelerate translational research by creating an federated biorepository
among caBIG participating institutions.
•
Joint grant with the Yale Cancer Center has been submitted to expand
support for the repository for clinical samples
YCCI:
Community Engagement
YCCI Community Engagement
YCCI Community Engagement
YCCI community engagement efforts:
• Community Alliance for Research and Engagement (CARE)
• Research and Network collaborations with the Yale School of Nursing
• Collaboration with the Yale Cancer Center to establish the Connecticut
Clinical Oncology Trials Network (CCOT)
• New Foundation Grant $800K award “Changing Life-Styles for Better
Health: a Model Program for Community Health Centers”
A Hill Health-Yale joint research study (Tamborlane)
•
Bright Bodies Program
YCCI - School of Nursing Community Engagement Efforts:
Yale received 1 of 6 Clinical Research Network Feasibility
Awards (CRNFAs).
• Yale University will collaborate with the Advanced
Practice Registered Nurse Research Network
(APRNet) to create a larger, interdisciplinary,
practice-based research network to conduct clinical
research studies within the community
• YCCI will support the APRN network with Pilot
funds for demonstration projects and administrative
support
Thank You
Questions?
For more information on YCCI:
Theresa C. Katz
(203) 785-6335
theresa.katz@yale.edu