Translational and Clinical Research Project

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Translational and Clinical Research Project
LSUHSC Research Council
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Translational
Claude Burgoyne, M.D. - Chairman Paul Fidel,
Ph.D James Hardy Jean Jacob, Ph.D. Michal
Jazwinski, Ph.D. Alistar Ramsay, Ph.D.
LSUHSC Research Council
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Translation Research Opportunities Approach

• Identity NIH funded investigators
• -3 questions by email
• Identify Center/Program Directors
• Identify Departmental Chairmen
• -3 questions by e-mail
• Compile responses in summary files

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Translation Research Opportunities
Recommentdations

• Create office of Translational research
• Seek a dynamic Director
• Focus on two areas of endeavor
• -TR initiatives within each Center and Program
• -Basic science forward initiative
• TR Initiatives within Center and Program
• -Why start here?

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Translation Research opportunities Basic
Science Forward Initiative

• Make TR office the center of scientific
  interaction
• Consider including Inter-disciplinary Research
• Foster three forms of interaction
• 1. Basic scientist seeking clinician
• 2. Clinician seeking basic scientist
• 3. Basic seeking basic scientist
• Three goals of Initiative
• 1. Publicize unique resources of LSUHSC
• 2. Create accessible database of scientists
• 3. Foster inter-action through personal
  inter-action

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Interdisciplinary
Greg Bagby, Ph.D. James Cairo, Ph.D. William
Chilian, Ph.D. - Chairman Paul Fidel,
Ph.D. Stephen Lanier, Ph.D. Carol Mason, M.D.
LSUHSC Research Council
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Interdisciplinary Research Recommendations

• New leadership needed in clinical departments to
  change the culture to
• active support for research       
• Sharing of IDC Recovery between schools and
  departments in multi-
• school and muiti-department grants        
• Creation of an Office of Interdisciplinary
  Research       
• Increased allocation of IDC Recovery to
  Departments with
• Interdisciplinary research support      
• Change the culture of the HSC administration
  from a "can't do" to a "can
• do" attitude

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Clinical Research in the HCSD
Michael Butler, M.D. William Cassidy,
M.D. Bennett DeBoisblanc, M.D. Kathy Hebert,
M.D. Ronald Horswell, Ph.D. John Hunt, M.D. -
Chairman Demetruis Porche, Ph.D. Patricia Snyder,
Ph.D. Mark Warner, Ph.D.
LSUHSC Research Council
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CLINICAL RESEARCH AND THE HCSD Recommendations
IRB

• Increase IRB Support Staff Increase frequency
  of meetings to
• 2X/month                                
• Internet-based processing of SAE's amendments,
  etc                                
• Have IRB members from all institutions subject
  to IRB cognizance 
• Consider IRB reciprocity with other institutions,
  e.g Tulane, Ochsner 
• Explore use of "Central IRB" for
  multi-institutional projects

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CLINICAL RESEARCH AND THE HCSD Recommendations
FINANCIAL

• Supplement investigator's salaries for doing
  funded research
• Conduct funds-flow analysis (Hospitals to LSU
  and LSU to
• Hospitals)                                   
• Research money generated at an institution
  should stay there 
• Permit competitive salaries for Research
  Coordinators         
• Improve COLA's for employees                     
                
• Develop on-line access by investigators to
  financial data
• Develop "internal CRO"/Facilitator Office at
  each hospital

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CLINICAL RESEARCH AND THE HCSD Recommendations
PEOPLE AND INFRASTRUCTURE

• Recruit personnel (physicians, nurses, etc) with
  research
• experience                                   
• Provide education and training to interested
  personnel in
• satellite hospitals                             
        
• Utilize a single electronic medical record
  system throughout
• the HCSD

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Clinical Trials Office
Luis Balart, M.D. Jill Gilbert, M.D. David
Martin, M.D. Steve Nelson, M.D. - Chairman Mark
Townsend, M.D. Michele  Zembo, M.D.
LSUHSC Research Council
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Clinical Trials Office

• The mission of the Clinical Trials Office is to
  organize and enhance operational processes that
  support clinical research and facilitate the
  timely initiation, execution, management, and
  completion of clinician trials at the LSU Health
  Sciences Center.
• The Clinical Trials Office will function as a
  single point-of-contact for all aspects of
  clinical trials research.
• The primary goals of the Clinical Trials Office
  are to offer a full spectrum of services that
  include 1) planning and conducting high quality
  clinical research trials, 2) enhancing
  administrative efficiency, and 3) assisting in
  the development and implementation of policies
  and procedures that assure compliance with
  prevailing regulations that govern the conduct of
  research in humans.

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These services are focused in five major areas

• Administrative
• Regulatory Compliance
• Specialized assistance with investigator
  initiated studies
• Education/Training
• Quality Control/Quality Assurance

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The Clinical Trials Office will help LSUHSC meet
its mission goals of excellence in patient care,
education, research, and community service.
LSUHSC is committed to providing world class
patient care with innovative therapies by
facilitating access to cutting edge clinical
research opportunities.
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Human Bio-specimen Core
Kathleen Dunlap, M.D. Kenneth Fallon, M.D. Jong
Kim, Ph.D. Sam Parthasarathy, Ph.D. -
Chairman Madhwa Raj, Ph.D. Eugene Woltering, M.D.
LSUHSC Research Council
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Advantages of a centralized Bio-Speciman Core

• Organized and streamlined tissue procurement and
  distribution
• Better catalouging and documentation of tissue
  and needs and availability
• Avalaiblilty of both normal and diseased tissues
• Easy access to tissues and blood samples
• Uniform compliance with Institutional, State,
  Federal, and HHS Privacy rule regulations
• Facilitation of translational research
• 7. Potential of more externally sponsored
  research

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Types of bio-specimens

• Surgical and autopsy tissues that are not used
  for diagnostic purposes
• 2. Fresh, frozen, formalin and alcohol-fixed
  paraffin embedded blocks
• 3. Fresh unfixed tissues and specimens
• 4. Cryo-freezed bio specimens
• 5. Isolated cells and fluids
• 6. Whole blood
• 7. Buffy coat or white cells
• 8. Plasma or serum

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Recommendations

• Of the existing centers at LSUHSC, the Cancer
  Center Core appears to be well developed and
  already in place. Despite a few minor
  deficiencies, the Cancer Center core is better
  suited to serve the needs of the campus. It is
  recommended that this core is further developed
  to utilize the procurement of normal tissues and
  blood samples. The Cancer Center Core would thus
  become the centralized and main bio-specimen core
  of the campus.
• It is recommended that a wet laboratory is
  setup to process blood samples to isolate cells,
  plasma/serum and to dissect out tissues.
• It is recommended that the Cancer Center Core
  incorporate additional members in their committee
  who would advise on the procurement of control
  and normal samples.
• It is recommended that specific people/protocols
  are identified for investigators to contact the
  core regarding the need of samples.
• Future directions
• The Bio-specimen core could be integrated with a
  clinical trials office.
• Novel cells derived from tissues could be
  immortalized (Technology Transfer)

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Education, Training and Mentoring
John Burgess, D.S.S. Kurt Varner, Ph.D. James
Diaz, M.D. Connie Romaine, RN, MN Judd Shellito,
M.D. Warren Summer, M.D. - Chairman
LSUHSC Research Council
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Education, Training and Mentoring for Clinical
Research Recommendations

• Promote clinical research                        
          
• Identify potential clinician
• researchers                                
• Attract potential clinical researchers           
               
• Design an Optimal Core Curriculum (Certificate
• with 9-12 graduate credit hours)                
           
• Supplement Certificate and Web-based programs
• to MS degree in Clinical Research

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Education, Training and Mentoring for Clinical
Research Recommendations

• Provide ongoing support (admin., space, funds)
  to
• new Clinician-researchers and their mentors
• Provide ongoing support for mentoring of
• clinician-researchers                          
• Jump-start and obtain external funds for
  program     
• Manage resistance to change

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Incentives and Disincentives
John Estrada, M.D. Steve Nelson, M.D. Augusto
Ochoa, M.D. - Chairman
LSUHSC Research Council
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Incentives/Disincentives in Clinical Research
Recommendations

• Immediate                                    
• Create a plan of monetary and promotion
  incentives for
• clinician-scientists                            
          
• Establish site for development of
  clinical/translational
• research                                    
• Establish research experience as major criterion
  for hiring
• faculty/chairs                                 
• Three to five years                              
         
• Strengthen existing clinician-scientists
  enabling them to
• mentor residents, fellows and junior
  faculty                  
• Develop a Clinical Trials Office

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Louisiana  Regional Translational Research Center
(LARTRC)

• NIH application for planning grant submitted
  today
• (150,000 x 1yr)
•                                     
• Consortium of LSUHSC-NO, LSUHSC-S, Pennington
  Research
• Center, HCSD
•                                     
• Other local institutions and major
  pharmaceutical companies
• to be considered
•                                     
• RFA for five year, 7 million grant due in 2006
•                                    
• Vision for seamless integration of translational
  research
• support and infrastructure
•                                     
• Priority areas to be determined, eg
  obesity/diabetes,
• cardiovascular disease, etc
•                                     
• Governance by Executive Committee appointed by
  LSU
• President