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 22Wednesday, April 22

12:00pm12:00pmThe Anlyan Center (TAC)The Anlyan Center (TAC)

N107 auditoriumN107 auditorium

• Lack of comprehensive training for fellows and faculty

• Lack of appropriate infrastructure to facilitate clinical and translational studies

The ProblemsFacing Clinical

Research at Yale in 2004

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)

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)

$-

$10,000,000

$20,000,000

$30,000,000

$40,000,000

$50,000,000

$60,000,000

CTSA as OriginallyAwarded

Revised Total Awardw/ Current Cuts

Renewal CappedAward

$57.3 M - $2.8 M- $10 M

Institutional Commitment to YCCI and Related Programs

From CTSA award through FY 09

$15.1M $15.4M $15.9M

$-

$2,000,000

$4,000,000

$6,000,000

$8,000,000

$10,000,000

$12,000,000

$14,000,000

$16,000,000

2007 2008 2009

YCCI Adminstration YCCI & YCC Research Services Educational Programs & Scholars

Faculty Programs Promoting Diversity Research Cores

Total Value of all NIH Research Connected to the Yale CTSA

(Researcher Utilizing Services, Scholars, and Mentors)

$97,083,051

$157,435,688

$124,300,594

$-

$20,000,000

$40,000,000

$60,000,000

$80,000,000

$100,000,000

$120,000,000

$140,000,000

$160,000,000

Grant Year 1 Grant Year 2 Grant Year 3 (to date)

8 months9 months

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

ProgramGrant Year 1 Number of Trainees

Grant Year 2 Number of Trainees

Grant Year 3 Number of Trainees

YCCI Faculty Scholars 15 19 13K Scholars 5 6 3IMP Trainees 10 14 18T32 Trainees 9 9 9T32 Trainees -Short-term 9 8 8

Total 48 56 51

CTSA Grant Total 1,591,928$ 2,730,746$ 3,125,531$ YSM 1,416,000$ 1,535,000$ 2,285,000$

Total All Programs 3,007,928$ 4,265,746$ 5,410,531$

Program Funding

Does not include 9 pending awards – April 1, 2009

YCCI Scholars Diverse Departmental & School Representation

School of Nursing6%

School of Public Health9%

Pediatrics12%

Medicine34%

Psychiatry18%

Child Study Center3%

Diagnostic Radiology6%

Neurobiology3%

Laboratory Medicine3%

Obstetrics and Gynecology

3%

Pharmacology3%

Medicine represents 6 different sub-specialties

~ $16.9 Million in Independent Funding

by Category for YCCI Scholars

Career Development- NIH

K33%

Research Grant - Foundation

7%

Career Development -

Industry Sponsored

1%

Research Grant - Industry

Sponsored1%

Career Development -

Research Foundation

5%

Clinical Trial-Investigator

Initiated5%Clinical Trial -

Industry Sponsored

1%

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

Services Then (GCRC) Now (ORS)

Biostatitical Support 1 5Education / Quality Assurance 0 1.5Informatics 2 4Financial Management 1 3Patient Recruitment 0 2Budget Development 0 2.5Protocol Development 0 3Research Nursing and Assistants 13 16Study Coordination 0 14

Total FTEs 17 51

One-stop Shopping

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.

Grant YearNumber 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

Difference Grant Year 2 to 3

10 -17 -18 -35

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.

Conference Room

Exam Room

Protocol Development

Education &Training New Research Staff

Exam Room

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 CategoryNumber of

Awards Total

Awarded Translational & Interdisciplinary Pilot Program 6 899,925$ Novel Clinical and Translational Methodologies Pilot Program 6 120,359$ Core Technologies Pilot Projects 4 53,303$ Community Engagement Partnership Pilot Projects 4 100,000$ Cancer Center Collaborative Pilot Project 1 25,000$ Novel Methodologies in Biostatistics and Informatics Pilot Program 1 25,000$ Junior Faculty Pilot Program 3 150,000$

Total 25 $ 1,373,587

Committee will be formed to review pilot progress

Departments Represented

Pilot and Collaborative Translational and Clinical Studies Funding

Orthopedics & Rehabilitation

4%

Pathology4%

Pediatrics12%

Psychiatry8%

School of Public Health12%

Surgery8%

Obstetrics and Gynecology

4%

Cancer Center8% Child Study Center

4%

Internal Medicine28%

Neurosurgery8%

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 LabEquipment for production of human MHC tetramers

UPLC system for phosphopeptide analysis Sequenom system for SNP genotypingQTrap mass spectrometer

MR Center Upgrade of 4T MR spectroscopy system

PET Center Enhancement of computer clusterLC/MS analysis system

$1.4 Million

Keck Biotechnology Lab

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 YouQuestions?

For more information on YCCI:

Theresa C. Katz (203) 785-6335

theresa.katz@yale.edu