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Brown Bag Luncheon Series: Presentation

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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 Timeline

6 Structure and Governance of YCCI

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 Cores

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 Engagement

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: THE END

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