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Clinical and Translational Science Institute Translating Research Into Improved Health David Nelson, MD Director, Clinical and Translational Science Institute.

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Presentation on theme: "Clinical and Translational Science Institute Translating Research Into Improved Health David Nelson, MD Director, Clinical and Translational Science Institute."— Presentation transcript:

1 Clinical and Translational Science Institute Translating Research Into Improved Health David Nelson, MD Director, Clinical and Translational Science Institute Associate Dean, Clinical Research

2 Outline Challenges – Health of our Nation – Impact of diabetes – The Translation Gap Opportunity – UF Clinical and Translational Science Institute Research metrics (T1-T4) Resources and services Clinical trials infrastructure Implementation science: personalized medicine

3 2000, UC Atlas of Global Inequality http://ucatlas.ucsc.edu/spend.php

4 Infant Mortality: Common Indicator of the Health of a Country

5 The Burden of Diabetes in the United States Approximately 21 million Americans have diabetes Diabetes is the sixth leading cause of death in the United States – approximately 225,000 deaths annually Diabetes accounts for 19% of health care expenditures in the US Direct and indirect cost associated with diabetes (2007) exceed $174 billion Source: American Diabetes Association

6 Age-adjusted Percentage of U.S. Adults Who Were Obese or Who Had Diagnosed Diabetes Centers for Disease Control and Prevention: National Diabetes Surveillance System http://www.cdc.gov/diabetes/statistics

7 Prevalence of Diabetes Macrovascular and Microvascular Complications MacrovascularMicrovascular American Association of Clinical Endocrinologists. State of Diabetes Complications in America Report. Available at: http://www.aace.com/newsroom/press/2007/images/DiabetesComplicationsReport_FINAL.pdf.

8 Community safety Education Family & social support Employment Built environment Environmental quality Income Unsafe sex Alcohol use Diet & exercise Tobacco use Access to care Quality of care Physical environment (10%) Social & economic factors (40%) Health behaviors (30%) Clinical care (20%) Health Factors Programs and Policies Health Outcomes Mortality (length of life) Morbidity (quality of life) Adapted from County Health Rankings model © 2010 UWPHI How Do We Build A Healthier America? Factors That Drive Health Outcomes

9 The Translation Gap for T1 Research More $ ≠ More Output

10 The Productivity Gap New Molecular Entities and Biologic License Applications Average R&D cost for each approved drug = $1.3 billion Nat Rev Drug Disc 2010;9:89-92

11 Clinical Research to Clinical Practice (T3/T4) -Lost in Translation. NEJM 349(9) 868-874 August 28 2003 …both health providers and members of the public, are not applying what we know. …we are not reaping the full public health benefits of our investment in research. …there is plenty of evidence that "old" research outcomes have been lost in translation as well.

12 Publication Bibliographic databases Submission Reviews, guidelines, textbook Negative results variable 0.3 year 6. 0 - 13.0 years 50% 46% 18% 35% 0.6 year 0.5 year 9.3 years Negative results Lack of numbers Inconsistent indexing Original research Acceptance Implementation E.A. Balas, 2000 It takes 17 years to turn 14 per cent of original research to the benefit of patient care

13 This is Not a New Problem: The Case of Scurvy 1593 - Sir Richard Hawkins recommended the following treatment for scurvy: "That which I have seen most fruitful for this sickness, is sour oranges and lemons." 1601- Lancaster shows that lemon juice supplement eliminates scurvy among sailors (non-randomized controlled trial) 1747- Lind shows that citrus juice supplement eliminates scurvy 1795- (194 years after Level 2 evidence) British Navy implements citrus juice supplement

14 The Translational Research Continuum at UF: An Expansion of T3 and T4 Research Basic Biomedical Discovery Clinical Efficacy Clinical Effectiveness Clinical Practice T1 What works under controlled conditions? (Translation to Humans) How can we change practice? (Translation to Practice) What is the effect on population health (Translation to Population Health) T2 T3 T4 “Bench” “Bedside” Community Practices Community Practices What works in real world settings (Translation to Patients) 2011 (n=912) 2008 (n= 862) CTSI Study Registry includes 9,401 human subject research protocols across four IRBs (medical and non-medical) 4,497 / 9,401 are considered medical and/or health related protocols 3,422 / 4,229 are categorized as translational research (T1 – T4)

15 UF VIVO Map of Science 13 Disciplines

16 National Institutes of Health Clinical and Translational Science Awards In 2006, NIH developed the Clinical and Translational Science Award (CTSA) as a program of the National Center for Research Resources The CTSA consortium works together as a national resource sharing a common vision to improve human health by helping scientists bridge laboratory discoveries to patient treatments National Strategic Goals: Improve the way biomedical research is conducted Reduce time it takes for discoveries to become treatments Engage communities in clinical research Train the next generation of clinical and translational researchers The 61 CTSA institutions are linked together to transform the local, regional, and national environment to increase the efficiency and speed of clinical and translational research

17 CTSA: The National Consortium

18 A Catalyst for Collaboration UF CTSI CTSA consortium 16 UF Colleges Health Care Systems Community Partners UF Institutes Corporate Partners

19 UF CTSI Organization

20 What Resources Are Available at CTSI? Successful development and implementation of a project Regulatory and submission help – Online irb submission (Click Commerce) – Budget and pricing tool, fixed medicare rates for research – Irb navigators, Clinical Trials.gov support Database development and support – REDCap or custom Research design and analysis support – Biostatistics, qualitative/quantitative analysis, informatics Communications research consulting (College of Journalism) Recruitment and retention services – StudyConnect, HealthStreet, ResearchMatch – IDR project: universal consent and cohort discovery – Community engagement coordinators

21 What Other Resources Are Available at CTSI? Clinical trial staff and facilities (inpatient/outpatient) – CRC and disease-specific research units – CTRB, Jax, and Lake Nona Pilot awards Education and Training programs for CTS VIVO: semantic approach to scholarly networking and discovery Core services Metabolomics (Tim Garrett, Dave Powell) Biorepository (Mike Clare-Salzler) Biobehavioral Core (Sara Joe Nixon) Genotyping Core (Julie Johnson) Human Imaging Core (Song Lai) Simulation (under development)

22 UF-Affiliated Research Networks Local/ Regional – North Florida Pediatric Community Research Network (Jacksonville area) – Jacksonville Health Equity Research Organization Practice-Based Research Network (JaxHERO) Statewide – Health IMPACTS for Florida (UF-FSU statewide research network) – Florida Neonatal Neurologic Network National – NHLBI Cardiovascular Cell Therapy Research Network (Carl Pepine) – NIDCR Dental Practice-Based Research Network (Valeria Gordan) – Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET, Nelson) – Network for Pancreatic Organ Donors with Diabetes (nPOD) – NIH Pharmacogenomics Research Network (Julie Johnson) – Sentinel Network for Community-Based Participatory Research (Linda Cottler)

23 UF-FSU Community Research Program Goal: Test interventions in physician practices; Translate research findings into improved health care quality; and Mentor medical students and trainees in conducting research and implementing research findings in practice. Two pilot projects: Sports related concussion surveillance and management (PI: Bauer) Health risk assessment among adolescents in primary care (PI: Shenkman) Funding: UF/FSU($500,000) State of Florida ($600,000) NIH ($ 473,000)

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25 Implementation Science UF&Shands Personalized Medicine Program Background – Human genome project completed in 2001 – Collins (NIH): expectation that an individual’s personal genome will be part of their medical record, from which information can be pulled to determine disease risk or guide treatment decisions Challenge – Despite the substantial number of important genetic discoveries made, there are limited examples of clinical translation to practice UF Objectives for Personalized Medicine Program – Engage UF&Shands Health System as leaders in genetic-guided care – Pre-emptively genotype on broad panel (256 SNPs) to mimic eventual reality of genomic data in EMR Prepare health informatics systems to handle increasing amounts of genetic data linked into EMR Define when and how to use genetic data in patient care

26 https://ufandshands.org/news/2012/uf-delivers-promise-personalized-medicine-heart- patients#!/-1/ Personalized Medicine Program- Launched June 25, 2012

27 Clopidogrel (Plavix): genetic polymorphism of CYP2C19 leads to reduced ability to activate clopidigrel and increased risk of cardiovascular complication “Front door” consent; Bioethics; Communications Research Biorepository Genotyping Core IDR; Bioinformatics; Research IT BMI ; Hospital IT; Epic CER, Economic Impact Clinical Translation in Genomics and Pharmacogenomics UF&Shands Personalized Medicine Initiative

28 NHGRI Genomic Medicine Proposal Implementation Science

29 UF CTSI’s Vision Improving the health of Florida’s communities with a focus on prevention and an emphasis on team science Learning Health System – “one which progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by-product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care” (IOM, 2007) – Put CTS research to work on health system priorities: quality, effectiveness, safety Linkage as “One Florida” – Cultivating an ability to work together with public and private partners to develop statewide collaborations and networks UM CTSA award and statewide initiatives Human Investment-Team Science – Develop and sustain current and future translational researchers and strengthen the research workforce – Team science approach as basis for both patient care and research


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