The Power of Collaboration
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- Maude Holt
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1 The Power of Collaboration PETRA KAUFMANN, M.D., M.SC. DIRECTOR, DIVISION OF CLINICAL INNOVATION DIRECTOR, OFFICE OF RARE DISEASES RESEARCH REDONNA CHANDLER, PH.D. DEPUTY DIRECTOR, DIVISION OF CLINICAL INNOVATION MARY PURUCKER, M.D., PH.D. DIRECTOR, CTSA PROGRAMHUBS MONICA SHAH, M.D., M.H.S., M.S.J DIRECTOR, TRIAL INNOVATION NETWORK KEN GERSING, M.D. DIRECTOR, INFORMATICS CTSA PROGRAM MEETING OCTOBER 25, 2016 CHICAGO, ILLINOIS ON BEHALF OF THE DIVISION OF CLINICAL INNOVATION
2 Health care and research in crisis Number of people over 60 has doubled since 1980 WHO Chronic diseases By 2025 chronic diseases will make up 70% of global disease burden WHO Increase in US health care spending is unsustainable (> $3 trillion, and >$10K per person) Forbes January 2015 $$ Transformative advances in technology, such as genomics and big data Biomedical workforce not as much changed in 50 years Large, reactive hospitals Academic currency remains publications incentivizing individual researchers Source: World Health Summit, Yearbook 2015
3 CTSA PROGRAM HUBS: Leading excellence and innovation locally Boston University, Case Western Reserve University, Children's Research Institute, Columbia University, Cornell University, Dartmouth College, Duke University, Einstein-Montefiore, Emory University, Georgetown-Howard Universities, Harvard University, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, New York University, Northwestern University, Ohio State University, Oregon Health & Science University, Pennsylvania State University, Rockefeller University, Scripps Research Institute, Stanford University, Tufts University, University at Buffalo, State University of New York, University of Alabama at Birmingham, University of California - Davis, University of California - Irvine, University of California - Los Angeles, University of California - San Diego, University of California - San Francisco, University of Chicago, University of Cincinnati, University of Colorado - Denver, University of Florida, University of Illinois at Chicago, University of Iowa, University of Kansas, University of Kentucky, University of Massachusetts, University of Miami, University of Michigan, University of Minnesota, University of New Mexico, University of North Carolina, University of Pennsylvania, University of Pittsburgh, University of Rochester, University of Southern California, University of Texas HSC at Houston, University of Texas HSC at San Antonio, University of Texas Medical Branch at Galveston, University of Texas Southwestern, University of Utah, University of Washington, University of Wisconsin - Madison, Vanderbilt University Medical Center, Virginia Commonwealth University, Wake Forest University, Washington University in St. Louis, Yale University Domain Task Forces Collaborating regionally and nationally Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Consortium-wide initiatives Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
4 NCATS DIVISION OF CLINICAL INNOVATION Partnering with key stakeholders to catalyze excellence and innovation in translational research and training Amit Chaudhari, Bernie Talbot, Carol Merchant, David Wilde, Erica Rosemond, Heather Baker, Joan Nagel, Kat Schwartz, Ken Gersing, Mary Purucker, Meryl Sufian, Michelle Culp, Michelle Simms, Monica Shah, Olga Brazhnik, Patricia Jones, Petra Kaufmann, PJ Brooks, Rebecca Katz, Redonna Chandler, Samantha Jonson, Scherri Jacobsen, Tiina Urv, Todd Wilson Partner with Domain Task Forces What we do with the CTSA Program hubs: Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Develop and support collaborative initiatives + special projects Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
5 How can we accelerate the path from discovery to health benefit? Clinic Research Integrating care and research Patient-reported outcomes Integrating data from multiple sources Harmonization 5 Collaboration
6 CTSA Program Hubs positioned at critical intersection Academic Research & Education Team science Broader range of career paths Accelerated access to information (e.g. pre-prints) Health Care Digitalization Trend toward larger health systems Care moves to the community 6
7 The CTSA Program Working together to bring more discoveries to health benefit Discovery Exploratory Research Confirmatory Research Clinic Health Outcomes 7
8 CTSA PROGRAM HUBS: Leading excellence and innovation locally Boston University, Case Western Reserve University, Children's Research Institute, Columbia University, Cornell University, Dartmouth College, Duke University, Einstein-Montefiore, Emory University, Georgetown-Howard Universities, Harvard University, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, New York University, Northwestern University, Ohio State University, Oregon Health & Science University, Pennsylvania State University, Rockefeller University, Scripps Research Institute, Stanford University, Tufts University, University at Buffalo, State University of New York, University of Alabama at Birmingham, University of California - Davis, University of California - Irvine, University of California - Los Angeles, University of California - San Diego, University of California - San Francisco, University of Chicago, University of Cincinnati, University of Colorado - Denver, University of Florida, University of Illinois at Chicago, University of Iowa, University of Kansas, University of Kentucky, University of Massachusetts, University of Miami, University of Michigan, University of Minnesota, University of New Mexico, University of North Carolina, University of Pennsylvania, University of Pittsburgh, University of Rochester, University of Southern California, University of Texas HSC at Houston, University of Texas HSC at San Antonio, University of Texas Medical Branch at Galveston, University of Texas Southwestern, University of Utah, University of Washington, University of Wisconsin - Madison, Vanderbilt University Medical Center, Virginia Commonwealth University, Wake Forest University, Washington University in St. Louis, Yale University Domain Task Forces Collaborating regionally and nationally Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Consortium-wide programs Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
9 Implementation: Hubs + Tufts Impact: Consortium-wide Streamlining/Sharing: Regional Hubs Strategic Management: Hubs + Acad. Med. Centers + NCATS Program Development: NCATS + PIs + Evaluators + Consultant COMMON METRICS: A Story of Collaborations Future Directions Best Practices: Nationwide
10 CTSA PROGRAM HUBS: Leading excellence and innovation locally Boston University, Case Western Reserve University, Children's Research Institute, Columbia University, Cornell University, Dartmouth College, Duke University, Einstein-Montefiore, Emory University, Georgetown-Howard Universities, Harvard University, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, New York University, Northwestern University, Ohio State University, Oregon Health & Science University, Pennsylvania State University, Rockefeller University, Scripps Research Institute, Stanford University, Tufts University, University at Buffalo, State University of New York, University of Alabama at Birmingham, University of California - Davis, University of California - Irvine, University of California - Los Angeles, University of California - San Diego, University of California - San Francisco, University of Chicago, University of Cincinnati, University of Colorado - Denver, University of Florida, University of Illinois at Chicago, University of Iowa, University of Kansas, University of Kentucky, University of Massachusetts, University of Miami, University of Michigan, University of Minnesota, University of New Mexico, University of North Carolina, University of Pennsylvania, University of Pittsburgh, University of Rochester, University of Southern California, University of Texas HSC at Houston, University of Texas HSC at San Antonio, University of Texas Medical Branch at Galveston, University of Texas Southwestern, University of Utah, University of Washington, University of Wisconsin - Madison, Vanderbilt University Medical Center, Virginia Commonwealth University, Wake Forest University, Washington University in St. Louis, Yale University Domain Task Forces Collaborating regionally and nationally Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Consortium-wide programs Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
11 CTSA Program Hub Activities During FY2016: A Very Collaborative Year
12 Clinical and Translational Science Awards 14 New CTSA Program Hubs awarded FY2016 University of Pennsylvania, University of California-Davis, University of California Los Angeles, University of California San Francisco, University of Pittsburg, Columbia University, Children s National Medical Center, University of Southern California, Rockefeller University, Yale University, University of Rochester, University of Illinois-Chicago, University of Kentucky, and Penn State University
13 CTSA Collaborative Innovation Awards 7 Awards Funded, 24 Collaborating Sites (PAR : U01) Boston University, Harvard University, University of Cincinnati, University of California Los Angeles, University of Alabama Birmingham, University of Kentucky, University of Chicago, University of Florida, University of Southern California, University of Utah, University of Illinois Chicago, University of North Carolina, Duke University, Wake Forest University, Northwestern University, University of Pennsylvania, Vanderbilt University, John Hopkins University, Stanford University, University of California Irvine, University of California San Diego, University of Massachusetts, J Craig Venter Institute, Inc., Research Triangle Institute
14 Enhancing Network Capacity Awards: 3 Awards Funded, 14 Collaborating Sites (PA : Admin Supplements) University of Utah, University of New Mexico, Johns Hopkins University, Harvard University, University of Michigan, Ohio State University, University of California Davis, Tufts University, University of Minnesota, University of Colorado, Weill Cornell, University of Florida, University of Pennsylvania, University of Wisconsin
15 Clinical and Translational Science Awards Moving ahead to FY17 Ongoing: CTSA Program Collaborative Innovation Awards, Network Capacity Administrative Supplements, CTSA Program Hub awards, SMART IRB, ACT New: PAR CTSA Exploratory Collaborative Innovation Awards (R21)
16 CTSA PROGRAM HUBS: Leading excellence and innovation locally Boston University, Case Western Reserve University, Children's Research Institute, Columbia University, Cornell University, Dartmouth College, Duke University, Einstein-Montefiore, Emory University, Georgetown-Howard Universities, Harvard University, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, New York University, Northwestern University, Ohio State University, Oregon Health & Science University, Pennsylvania State University, Rockefeller University, Scripps Research Institute, Stanford University, Tufts University, University at Buffalo, State University of New York, University of Alabama at Birmingham, University of California - Davis, University of California - Irvine, University of California - Los Angeles, University of California - San Diego, University of California - San Francisco, University of Chicago, University of Cincinnati, University of Colorado - Denver, University of Florida, University of Illinois at Chicago, University of Iowa, University of Kansas, University of Kentucky, University of Massachusetts, University of Miami, University of Michigan, University of Minnesota, University of New Mexico, University of North Carolina, University of Pennsylvania, University of Pittsburgh, University of Rochester, University of Southern California, University of Texas HSC at Houston, University of Texas HSC at San Antonio, University of Texas Medical Branch at Galveston, University of Texas Southwestern, University of Utah, University of Washington, University of Wisconsin - Madison, Vanderbilt University Medical Center, Virginia Commonwealth University, Wake Forest University, Washington University in St. Louis, Yale University Domain Task Forces Collaborating regionally and nationally Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Consortium-wide programs Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
17 Trial Innovation Network Challenging the Goliath of Clinical Trials
18 Challenges in Clinical Trials Are Formidable Trial Start Up Fragmented Operating Models Recruitment Challenges Lack of Engagement of Site Investigators, Providers, Participants High Costs Protocol Complexity Fewer High Quality Trials Insufficient Evidence to Inform Clinical Care
19 Challenges in Clinical Trials Are Formidable IRB Review ~112 Days Contract Execution ~91 Days Trial infrastructure duplicated and not aligned with existing resources Since % decline in enrollment Protocols often developed without input from key stakeholders Study Procedures 150 CRF pages $160M to $2B Primary drivers data collection, data management, study administration Fewer High Quality Trials Insufficient Evidence to Inform Clinical Care
20 Challenges in Changing Research Culture Are Formidable Disrupting standard NIH clinical trial models Breaking down silos Rethinking incentives Harmonizing and streamlining processes Embracing change and uncertainty
21 But Challenges Can Open Doors
22 Strategy Trial Innovation Network Thinking Strategically Trials with patient-centered endpoints that answer clinical questions and inform clinical practice A Network that aligns clinical trials infrastructure with existing local infrastructure, optimizing resources Innovation, quality by design, evidence-based recruitment National laboratory to study and improve multi-center clinical trials A Network built in stages Our Slingshots Talent, expertise, size, and diversity of CTSA Program Influential leaders Experience of the TICs and RIC NIH public mandate and power to convene
23 Trial Innovation Network Thinking Collaboratively
24 Trial Innovation Network Thinking Audaciously A National Clinical Trials Superhighway
25 CTSA PROGRAM HUBS: Leading excellence and innovation locally Boston University, Case Western Reserve University, Children's Research Institute, Columbia University, Cornell University, Dartmouth College, Duke University, Einstein-Montefiore, Emory University, Georgetown-Howard Universities, Harvard University, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, New York University, Northwestern University, Ohio State University, Oregon Health & Science University, Pennsylvania State University, Rockefeller University, Scripps Research Institute, Stanford University, Tufts University, University at Buffalo, State University of New York, University of Alabama at Birmingham, University of California - Davis, University of California - Irvine, University of California - Los Angeles, University of California - San Diego, University of California - San Francisco, University of Chicago, University of Cincinnati, University of Colorado - Denver, University of Florida, University of Illinois at Chicago, University of Iowa, University of Kansas, University of Kentucky, University of Massachusetts, University of Miami, University of Michigan, University of Minnesota, University of New Mexico, University of North Carolina, University of Pennsylvania, University of Pittsburgh, University of Rochester, University of Southern California, University of Texas HSC at Houston, University of Texas HSC at San Antonio, University of Texas Medical Branch at Galveston, University of Texas Southwestern, University of Utah, University of Washington, University of Wisconsin - Madison, Vanderbilt University Medical Center, Virginia Commonwealth University, Wake Forest University, Washington University in St. Louis, Yale University Domain Task Forces Collaborating regionally and nationally Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Consortium-wide programs Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
26 CD2H: WE VE BEEN LISTENING! GREAT IDEAS Creating a data ecosystem Interoperability Innovative use of informatics technology Enhancing training Multisite clinical trials Research networking CTSA PROGRAM DATA 2 HEALTH (CD2H) Sustainable collaboration Good Data Practice (GDP) Software standards for interoperability Collaborative tools Informatics training and education Evaluate Impact
27 THE CHALLENGE IS IMMENSE omics Chemistry Cell Social Interv ention Systems Molecules Registry EMR
28 THE CHALLENGE IS IMMENSE omics Chemistry Cell Social Interv ention Systems Molecules Registry EMR
29 THE OPPORTUNITIES ARE ENDLESS omics Cell Social Intervention Chemistry Molecules Systems Registry EMR
30 EXECUTION IS HARD Environment Metadata Curation Standards Intervention
31 INTERDISCIPLINARY COLLABORATION Informatics - Artificial intelligence, Behavior informatics, Biometrics, Cognitive science, Computer science, Communication studies, Information science, Information systems, Information theory, Information technology, Knowledge Management, Robotics, Urban informatics, Bio Informatics, Medical Informatics, Translational Informatics, Chemical Informatics omics Cell Systems Registry Social EMR Chemistry Molecules Intervention Interests - Clinical Decision Support, Leaning Health System, AI, Visualization, NOSQL, Simple Trials, Direct Submissions, FHIR Forms, Mobile Health, Patient Consents, Registries, MPI, Big Data, Semantic Web, Dynamic Ontologies, PMI, Deep Phenotyping, Distributed Computing, HBASE, Social History, Social Media, Public Private, Partnerships, Collaborative Tools, SBIR, Chemistry, omics, pharmacology, data-driven ontologies, graph models, IHE, Resource Sharing
32 CHALLENGE BOLD IDEAS TO HEALTH omics Cell Systems Registry Social EMR Chemistry Molecules Intervention Our Goal How does this help patients Collaborate This is to big for one person, one team, one institution Be FAIR Data is our nature resource (Findable, Accessible, Interoperable, Reusable) Analytics/Visualization Both are needed to conceptualize the information
33 CTSA PROGRAM HUBS: Leading excellence and innovation locally Boston University, Case Western Reserve University, Children's Research Institute, Columbia University, Cornell University, Dartmouth College, Duke University, Einstein-Montefiore, Emory University, Georgetown-Howard Universities, Harvard University, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, New York University, Northwestern University, Ohio State University, Oregon Health & Science University, Pennsylvania State University, Rockefeller University, Scripps Research Institute, Stanford University, Tufts University, University at Buffalo, State University of New York, University of Alabama at Birmingham, University of California - Davis, University of California - Irvine, University of California - Los Angeles, University of California - San Diego, University of California - San Francisco, University of Chicago, University of Cincinnati, University of Colorado - Denver, University of Florida, University of Illinois at Chicago, University of Iowa, University of Kansas, University of Kentucky, University of Massachusetts, University of Miami, University of Michigan, University of Minnesota, University of New Mexico, University of North Carolina, University of Pennsylvania, University of Pittsburgh, University of Rochester, University of Southern California, University of Texas HSC at Houston, University of Texas HSC at San Antonio, University of Texas Medical Branch at Galveston, University of Texas Southwestern, University of Utah, University of Washington, University of Wisconsin - Madison, Vanderbilt University Medical Center, Virginia Commonwealth University, Wake Forest University, Washington University in St. Louis, Yale University Domain Task Forces Collaborating regionally and nationally Methods Processes Collaboration Engagement Understudied Populations Informatics Workforce Development Consortium-wide programs Collaborative Innovation Awards Trial Innovation Network CTSA Program Data Harmonization Future Innovations & Partnerships
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