Indiana Clinical and Translational Sciences Institute A statewide - - PowerPoint PPT Presentation

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Indiana Clinical and Translational Sciences Institute A statewide - - PowerPoint PPT Presentation

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Indiana Clinical and Translational Sciences Institute A statewide Laboratory for accelerating Clinical and Translational Research ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH www.indianactsi.org Indiana CTSI Today

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Indiana Clinical and Translational Sciences Institute

A statewide Laboratory for accelerating Clinical and Translational Research

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

 State-wide laboratory created to transform health sciences research and health care delivery.  A strong Indiana public-private partnership that extends beyond basic research and looks at specific programs to improve the health of Hoosiers and all Americans.  Part of a National Consortium of 60 Academic Health Partners working together to accelerate biomedical discoveries across 30 states and DC.

Indiana CTSI Today

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Indiana CTSI Partners – Providing Leveraging Opportunities Throughout the State

Purdue University Indiana University

Regenstrief Institute IU Health Roche Diagnostics Indiana State Government Cook Group, Inc Richard M. Fairbanks Foundation Eli Lilly and Company

Wishard Health Services Roudebush VA Medical Center

BioCrossroads

University of Notre Dame

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Existing Programs

Programs of the Indiana CTSI application Key function 'Section' of the RFA that is met by this section (Assuming these required elements stay)

  • 1. Administration (Shekhar)
  • 1. Overview
  • 2. Governance (Shekhar)
  • 2. Governance
  • 3. Novel Translational Methodologies and Pilot Studies

Lead: Dr. Denne

  • 3. Novel Translational Methodologies and Pilot Studies
  • 4. Biomedical Informatics

Lead: Dr. Tierney

  • 4. Biomedical Informatics
  • 5. Biostatistics, Epidemiology and Research Design (BERD)

Lead: Dr. Hui

  • 5. Design and Biostatistics

6 & 7. Bioethics, Regulatory Affairs and Subject Safety (BRASS) Lead: Dr. Meslin

  • 6. Regulatory Knowledge and Support
  • 8. Participant and Clinical Interaction Resources (PCIR)

Lead: Drs. Shekhar and Denne

  • 7. Participant and Clinical Interaction Resources (PCIR)
  • 9. Community Health Engagement Program (CHEP)

Lead: Drs. Marrero and Miller

  • 8. Community Engagement and Research
  • 10. Translational Technologies and Resources (TTR)

Lead: Dr. Cornetta

  • 9. Translational Technologies and Resources (TTR)
  • 11. Research Education, Training and Career Development

(including disease modeling) Lead: Dr. Kroenke

  • 10. Research Education, Training and Career

Development

  • 12. Tracking and Evaluation

Lead: TBN and Shekhar

  • 11. Tracking and Evaluation
  • 13. Implementation Plan and Milestones

Lead: Dr. Shekhar

  • 12. Implementation Plan and milestones
  • 14. Biomedical Engineering and Nanotechnology

Lead: Dr. Wodicka Optional section

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Renewal Strategy

  • 15. Personalized Therapeutic Program

(partnership with Institute for Personalized Medicine, Bioinformatics) Optional section; New

  • Dr. Flockhart to lead
  • 16. Targeted Molecules and Diagnostics

Program (partnership with relevant centers at IUSM, Purdue, ND and IUB) Optional section; New

  • Drs. Zhang and Ratliff to lead
  • 17. Global Health Program (partnership

with Center for Global Health) Optional section; New

  • Dr. Inui and TBN from ND to lead
  • 18. Health Implementation and

Innovation Program (in partnership with proposed Innovation and Implementation Sciences Institute, IUH, Wishard, IHIE, etc.) Optional section; New

  • Drs. Boustani and Beyt to lead
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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Improve Health and Economy of Indiana by:

  • 1. Creating Translational Research Acceleration

Programs

  • 2. Training a New Cadre of Translational

researchers

  • 3. Fostering Robust Community Engagement
  • 4. Streamlining Clinical Research Resources
  • 5. Leveraging Resources of the Greater Indiana

Community

Mission and Goals

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

PDT projects

T1 Basic Science T2 Human Clinical Research T3 Implementation and Outcomes Research

142 197 20

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Challenge:

  • Need to Create Innovative Training Programs and develop future

workforce CTSI Solution:

  • 1. Clinical Faculty Career Development Awards (12 awarded in 2011)
  • 2. Basic Research Faculty career development awards (5 in 2011)
  • 3. Graduate Training (20 awarded)
  • 4. Masters Degrees

– MS in Clinical research for MD, Nurses, Clinicians – MS in Translational Sciences just started this year

  • 5. Program for Research coordinator certification (RCCP)
  • 6. Professional, Undergraduate, and high school Medical Research

Fellowships

  • 7. Developing: International Translational Research Programs (Kenya,

Australia, others)

Goal 2. Training Translational Researchers

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Significant Results to date:

  • 1. 3 K awardees obtained their R01s this year

(1 got 2 R01s)

  • 2. Starting an MD, MS program
  • 3. Planning a DDS, MS program

Goal 2.

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Challenge:

  • Improve clinical research access through health literacy,

research participation and Biobanking in the community

  • Increase collaboration among community and research partners

throughout Indiana to improve research, health and healthcare CTSI Solution:

  • Community Health Enhancement Program (CHEP)
  • Over 280 active Community Partners engaged Community
  • Community Advisory Council (CAC) established
  • Focus areas meet monthly, entire group annually
  • A New mechanism developed to supplement subject

recruitment similar To PDTs

Goal 3. Robust Community Engagement

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Challenges:

  • Regulatory barriers need to be shortened

through contracts, IRBs

  • Need to engage more patients in clinical studies
  • Need a place to conduct pivotal studies

faster, better

  • Need to establish a statewide Biobank

Goal 4. Streamlining and Enhancing Clinical Research Resources

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

4 1 2 3 5

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Regulatory Processes

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Significant Results to date:

  • 1. Contract time Reduced to <21 days
  • 2. IRB – working on improvements –

Currently around 53 (84) days Goal 4.

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Subject Recruitment Office

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Clinical Research Resources

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Bio-banking Program

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

  • 1. We now have >4000 annotated samples
  • 2. We have identified have targeted patients

with unique phenotypes:

  • a. 30 years of medical records seen last year (6,700)
  • b. 5 years of full pharmacy records (6,000).

Goal 4. BioBank

HTN (Hypertension) 4699 79.44 DM (Diabetes Mellitus) 2265 38.29 CHF (Congestive Heart Failure) 661 11.17 CAD (Coronary Artery Disease) 838 14.17 RAD (Reactive Airway Disease) 2417 40.86 CVA (stroke) 492 8.32 Renal Disease/Failure 223 3.77 MI (Myocardio Infarction) 829 14.02 Cancer 459 7.76 Liver Problem 162 2.74

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org Clinical and Translational Science Volume 4, Issue 2, pages 80-83, 4 APR 2011

Goal 5. Leverage Community Resources

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ACCE L E RAT ING CL INI CAL AND T RANSL AT IONAL RE SE ARCH

www.indianactsi.org

Other Significant Results to date:

  • 1. Developed “i2i” with Cook; Now

developing system wide device trial capability

  • 2. Indiana Health Study - Fairbanks Institute

for Healthy Communities conducting a longitudinal study of the Indianapolis population Goal 5. Leverage Community Resources