Yale Center for Clinical Investigation: From the lab, to the clinic to the community

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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 1200pm The Anlyan Center (TAC) N107
auditorium
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The ProblemsFacing Clinical Research at Yale in
2004

• Lack of comprehensive training for fellows and
  faculty
• Lack of appropriate
• infrastructure to facilitate clinical and
  translational studies

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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 theYale Center
for Clinical Investigation (YCCI)
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Programmatic Goals

• 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

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YCCI History and Timeline
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Structure and Governance of YCCI
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How is YCCI Supported?

• Clinical and Translational Science Award (CTSA)
  funded by NCRR
• Institutional Support
• Fee for services charges to Investigator grants

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The CTSA (Direct Indirect Costs)
57.3 M
- 2.8 M
- 10 M
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Institutional Commitment to YCCI and Related
Programs From CTSA award through FY 09
15.9M
15.1M
15.4M
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Total Value of all NIH Research Connected to the
Yale CTSA (Researcher Utilizing Services,
Scholars, and Mentors)
8 months
9 months
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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

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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

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YCCI Educational Programs
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A Comprehensive Training Program for the Next
Generation of Clinical and Translational
Scientists

• The Scholars and Mentors are the Educational
  Centerpiece of YCCI

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Leadership Team

• Judy Cho, MD, Co-Director for Education
• (YCCI Scholar Program, Career
  DevelopmentTranslational 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 ProgramsClinical Research)
• Joseph Craft, MD, Director of Investigative
  Medicine Program
• John Forrest, Jr., MD, T32 Program Director
• (focus on T32 Program Development Training
  Program Integration)

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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

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YCCI Educational Programs

• K Scholars
• YCCI Scholars
• Investigative Medicine Program Trainees
• T32 Trainees

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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
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YCCI Scholars
Does not include 9 pending awards April 1, 2009
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YCCI Scholars Diverse Departmental School
Representation
Medicine represents 6 different sub-specialties
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16.9 Million in Independent Funding by
Category for YCCI Scholars
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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 scholars project.
• Provision of a small amount research support for
  participation in the program.
• 100 Acceptance of Invitations to Participate!

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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.

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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.

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Masters Program

• Masters Program Overseen By YCCI
• Co-Directors of Research and
• Yale School of Medicine Office of Education

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Masters Program

• Courses include
• Epidemiology
• Biostatistics
• Drug design (bench to bedside)
• Practical and Ethical Issues in
  Clinical/Translational Research
• Electives

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New Program

• Yale Pediatric Faculty Scholars Program
• Goal To encourage innovative research and
  collaboration among faculty who do NOT
  necessarily have 75 protected time for research

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YCCI Office of Research Services (ORS) and the
Clinical Research Units, including former GCRC)
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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

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ORS Increases in Services and Staff

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Our Progress Improvements in the Research
Timeline

• 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.

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Participant Clinical Interaction Resource
(PCIR)Components at Yale

• Hospital Research Unit (HRU) former GCRC Unit
• New research unit at 2 Church Street South

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Office of Research Services (ORS) at 2 Church
Street South
In-patient Unit
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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

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YNHH Clinical Research Unit (former GCRC)
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ORS Aim 2 Acquire, Renovate and Equip ORS and
PCIR space _at_ Church St.
Exam Room
Education Training New Research Staff
Conference Room
Exam Room
Protocol Development
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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

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Recruitment Campaign
Help Develop the Medicine of Tomorrow http//www.
yaletrials.org/
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Recruitment Campaign
300 people at the fair requesting additional
information regarding participation
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YCCI Pilot Grant Programs
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Pilot Collaborative Translational and Clinical
Studies Funding 2 Yrs
Committee will be formed to review pilot progress
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Departments Represented
Pilot and Collaborative Translational and
Clinical Studies Funding
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YCCI Research Cores
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Technology Core Clusters

• Imaging
• Genomics and Proteomics
• Human Specimen Analysis and Immune Monitoring
• Developing
• Physiology and Metabolism
• Cognition and Behavior
• Drug Development

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Year 1 Strategic Investments in Cores
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Efforts to Increase Core Utilization

• Developed websites and scheduling programs
• Newsletter
• Core pilots program
• launched
• Expansion of PET Center capacity

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YCCI Biostats and Study Design
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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.

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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

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YCCI Informatics
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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)

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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

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YCCI Community Engagement
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YCCI Community Engagement
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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

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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

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Thank YouQuestions? For more information on
YCCITheresa C. Katz [phone]
theresa.katz_at_yale.edu