Re-engineering Clinical Research USF Health

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1 Re-engineering Clinical Research USF Health Presented to: Health Sciences & Research Workgroup Board of Trustees - USF August 17, 2006 Abdul S. Rao, MD, MA, DPhil Senior Associate Vice President Office of Research, Graduate & Postdoctoral Affairs

2 The Importance of Translational and Clinical Research in Academic Health Science Centers and Affiliated Hospitals

3

4 https://services.aamc.org/publications/showfile.cfm?file=version58.pdf&prd_id=150&prv_id=176&pdf_id=58

5 Recommendation of the AAMC s Task Force II on Clinical Research - I Every future physician should receive a thorough education in the basic principles of translational and clinical research, both in medical schools and during residency training LCME should add education in translational and clinical research to the requirement for medical school accreditation ACGME should embed understanding of translational and clinical research within its required core competencies of residency programs

6 Recommendation of the AAMC s Task Force II on Clinical Research - II Training for translational and clinical investigators should comprise an advanced degree. Sufficient support should be given to new junior faculty who are translational and clinical investigators to maximize their probability of success Institutions should provide central oversight, administration, and support for the essential infrastructure required by the translational and clinical research enterprise

7 Central oversight, administration, and support for translational and clinical research Consistent with intent of the recently issued NIH Clinical and Translational Science Awards

8 Recommendation of the AAMC s Task Force II on Clinical Research - III Academic medical institutions should establish collaborations with community healthcare providers and practice-based research networks to broaden the diversity and size of the population base for translational and clinical research Medical schools and their affiliated teaching hospitals should explicitly recognize and vigorously promote translational and clinical research as a core mission, and accord it a very high priority for institutional funding

9 NIH CTSA Awards: A Home for Clinical and Translational Science Biomedical Informatics Clinical Research Ethics Clinical Resources Biostatistics CTSA HOME Trial Design Regulatory Support Advanced Degree-Granting Programs Participant & Community Involvement Industry Other Institutions NIH, 2006

10 Strategic Goals for Enhancing Translational & Clinical Research Establish an Institute for Translational and Clinical Research (ITCR) - Create Central Administrative Oversight & Adequate Infrastructure Create Program-based Clinical Research Networks involving both USF and Non-USF Physicians - Enhance Community Physician Involvement Aggressively and Successfully Compete for New Training Grants - Enhance Education & Training opportunities All Clinical Faculty in the COM Must Be Involved in Translational and/or Clinical Research as a PI, CO-PI, or Co-Investigator by Enhance Student, Resident, & Physician Involvement in Translational & Clinical Research

11 Institute for Translational & Clinical USF Health Entrepreneurial..to meet the needs of today s stakeholders and corporate partners One-stop shop for: Investigators (USF and Non-USF Faculty) Clinical Coordinators Patients Referring MD s Corporate Partners (pharmaceutical, biotech, medical device companies, etc.) Contract development, negotiation, & management services Appropriate billing and collection services Biostatistics and epidemiology support Facilitate submission of protocols to the IRB s Education and training of students, staff, and faculty Oversight in the proper conduct of human subject research Data management and analysis services

12 Organizational Structure: Institute for Translational & Clinical USF Health Sr. Associate Vice President (Abdul S. Rao) Associate VP (TBA) Office of Clinical TGH Director (Patti Simmons, PhD) Other Potential Affiliate Sites Office of Clinical Research (For USF Faculty ONLY) Pre-Award Biostatistics* Post-Award Education* Pre-IRB Review Protocols Marketing* Information technology* Database Development & Management *services offered to both USF and non-usf faculty

13 Organizational Structure: Office of Clinical Tampa General Hospital President and CEO - TGH (Mr. Ron Hytoff) Medical Director (Abdul S. Rao, MD, MA, DPhil) Director (Patti Simmons, PhD) Clinical Coordinators Clinical Research Nurse Clinical Research Nurse Research Parmacy Pharmacist (Shacreyett Burton) Pharmacy Technician Administrative Assistant (Heather Portwood) Research Finance Specialist (Vivian Foster) Research Finanace Specialist Research Compliance Analyst (Lori Banctel) Research Manager (Cathie DeLuna) Project Coordinator Project Coordinator

14 Research TGH Erfan Albakri, MD (Florida Neurovascular Inst) Keith Aldahano (TGH - Radiology) Lori Banctel, MPH (TGH - OCR) William Baugh (TGH - Pastoral Services) Shacreyette Burton, PharmD (TGH - Invest. Pharmacy) Robbie Brauner, RN (TGH - Cardiovascular) Jane Carver, PhD (USF - Pediatrics) Arzu Ilercile, MD (USF - Cardiology) Janet Davis, RN (TGH - Acute Care Services) Cathie DeLuna, RN (TGH - OCR) Loren Dyer (TGH - Reimbursement) Seema Eichler, PhD (TGH - Psychology) Michael Hoffman, MD (USF - Neurology) Sally Houston, MD (USF - Infectious Disease) Dale Knight (TGH - Surgical Services) Fadi Matar, MD (Florida Cardiovascular Institute) James Mayes, MD (LifeLink) Victor Boyers, MD (LifeLink) Steven Mester, MD (Bay Area Cardiology) Elamin Elamin, MD (USF Anesthesia) Bruce Zwiebel, MD (Radiology Associates) Mary Kutash (TGH - Nursing) LouAnn Moriss (TGH - Emergency Medicine) Charles Paidas, MD (USF - Pediatric Surgery) Richard Paula, MD (USF - Emergency Medicine) Abdul Rao, MD, MA, DPhil (Chair and Medical Dir) Mark Rolfe, MD (USF - Internal Medicine) Roy Sanders, MD (Florida Orthopedic Institute) Patti Simmons, PhD (TGH - OCR) John Sinnott, MD (USF - Infectious Diseases) Sherri Swan (TGH - Risk Management) Harry VanLoveren, MD (USF - Neurosurgery) Ray Widen, PhD (TGH - Laboratory)

15 Education and Training

16 USF Health Training Grants - I USF Scholars in Patient Oriented Research (K-30) National Institutes of Health, $300,000 Clinical Scholars in Oncology National Cancer Institute, $749,445 Summer Medical School Research Support American Heart Association, $10,800 Training in Primary Care Medicine and Dentistry Health Resource & Services Administration, $151,200

17 USF Health Training Grants - II Public Health Traineeship Health Resource & Services Administration, $59,802 Education Resource Training Grant National Institute of Occupational Safety and Health, $1,072,920 Maternal & Child Health Epidemiology Training Grant Secretary of Health & Human Services, $26,000

18 USF Health Training Grants - III Professional Nurse Traineeship Health Resource & Services Administration, $79,175 Rural Underserved Family Nurse Practitioner Program Health Resource & Services Administration, $252,986

19 NIH CTSA Funding Opportunities RM : Planning Grant RFA for Institutional CTSAs Allows more time to prepare a CTSA application One time solicitation for one-year award ~50 awards, $150K direct costs; $11.5 M total RM : Institutional Clinical and Translational Science Award RFA 4-7 awards at $4-6 million each

20 RM : Planning Grant RFA for Institutional CTSAs USF Health has submitted this award application The application has been scored and it is highly likely that we will be funded This would allow us to partially support the establishment of the Institute for Translational & Clinical Research This would also afford USF Health a place in the queue for submitting an institutional CTSA application by or before 2011

21 Other Important Assets at USF Health/USF Department of Epidemiology and Biostatistics Pediatrics Epidemiology Center Carol and Frank Morsani Center for Advanced Healthcare USF Health Pavilion South Center for Advanced Medical Learning & Simulation USF Research Park

22 Involvement of Device & Pharmaceutical Industry Translational & Clinical Research USF Faculty, Residents, Staff, and Students Education and Training of Physician Scientists and Students Acquisition of new knowledge Improved quality of patient care Diverse therapeutic portfolio Recruitment & retention of quality basic scientists, physicians, residents, students, etc. Involvement of Community Physicians Involvement of Affiliate Hospitals

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