1. Brown Bag Luncheon Series: Presentation
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

2. 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
NEXT SLIDE SUMMARY:
Clinical research is risky business

3. 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)

4. 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.
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 4

5. YCCI History and Timeline5

6. Structure and Governance of YCCI6

7. How is YCCI Supported?
Clinical and Translational Science Award (CTSA) funded by NCRR
Institutional Support
Fee for services charges to Investigator grants

8. The CTSA (Direct & Indirect Costs)
$57.3 M
- $2.8 M
- $10 M 8

9. Institutional Commitment to YCCI and Related Programs From CTSA award through FY 09

10. Total Value of all NIH Research Connected to the Yale CTSA (Researcher Utilizing Services, Scholars, and Mentors)
9 months
8 months 10

11. 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

12. 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

13. YCCI: Educational Programs

14. A Comprehensive Training Program for the Next Generation of Clinical and Translational Scientists
The Scholars and Mentors are the Educational Centerpiece of YCCI

15. 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)

16. 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:

17. YCCI Educational Programs
K Scholars
YCCI Scholars
Investigative Medicine Program Trainees
T32 Trainees

18. 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

19. YCCI Scholars
Does not include 9 pending awards – April 1, 2009 19

20. YCCI Scholars Diverse Departmental & School Representation
Medicine represents 6
different sub-specialties 20

21. ~ $16.9 Million in Independent Funding by Category for YCCI Scholars

22. 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! 22

23. 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.

24. 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.

25. Master’s Program Masters Program Overseen By YCCI
Co-Directors of Research and
Yale School of Medicine Office of Education

26. Master’s Program Courses include Epidemiology Biostatistics
Drug design (bench to bedside)
Practical and Ethical Issues in Clinical/Translational Research
Electives

27. 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

28. YCCI: Office of Research Services (ORS) and the Clinical Research Units, including “former GCRC”)

29. 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

30. ORS: Increases in Services and Staff

31. 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.

32. Participant & Clinical Interaction Resource (PCIR) Components at Yale
Hospital Research Unit (HRU) former GCRC Unit
New research unit at 2 Church Street South

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

34. Office of Research Services (ORS) YNHH 10-6 and 2 Church Street So
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

35. YNHH Clinical Research Unit (former GCRC)

36. ORS Aim 2: Acquire, Renovate and Equip ORS and PCIR space @ Church St.
Exam Room
Education &
Training New Research Staff
Conference Room
Exam Room
Protocol Development

37. 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

38. Help Develop the Medicine of Tomorrow
Recruitment Campaign
Help Develop the Medicine of Tomorrow

39. Recruitment Campaign
300 people at the fair requesting additional information regarding participation

40. YCCI: Pilot Grant Programs

41. Pilot & Collaborative Translational and Clinical Studies Funding: 2 Yrs
Committee will be formed to review pilot progress 41

42. Departments Represented
Pilot and Collaborative Translational and Clinical Studies Funding
Departments Represented 42

43. YCCI: Research Cores

44. Technology Core Clusters
Imaging
Genomics and Proteomics
Human Specimen Analysis and Immune Monitoring
Developing
Physiology and Metabolism
Cognition and Behavior
Drug Development

45. Year 1 Strategic Investments in Cores45

46. Efforts to Increase Core Utilization
Developed websites and scheduling programs
Newsletter
Core pilots program
launched
Expansion of PET Center capacity 46

47. YCCI: Biostats and Study Design

48. 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.

49. 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

50. YCCI: Informatics

51. 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) 51

52. 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 52

53. YCCI: Community Engagement

54. YCCI Community Engagement54

55. 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 55

56. 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 56

57. Thank You Questions. For more information on YCCI: Theresa C
Thank You Questions? For more information on YCCI: Theresa C. Katz (203)
NEXT SLIDE SUMMARY:
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