Translational and Clinical Research Project

LSUHSC Research Council

Claude Burgoyne, M.D. - ChairmanPaul Fidel, Ph.D

James HardyJean Jacob, Ph.D.

Michal Jazwinski, Ph.D.Alistar Ramsay, Ph.D.

LSUHSC Research Council

Translational

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

• 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?

Translation Research Opportunities; Recommentdations

• Make TR office the center of scientific interaction

• Consider including Inter-disciplinary Research

• Foster three forms of interaction1. Basic scientist seeking clinician 2. Clinician seeking basic scientist3. Basic seeking basic scientist

• Three goals of Initiative 1. Publicize unique resources of LSUHSC 2. Create accessible database of scientists3. Foster inter-action through personal inter-action

Translation Research opportunities; Basic Science Forward Initiative

Greg Bagby, Ph.D.James Cairo, Ph.D.

William Chilian, Ph.D. - ChairmanPaul Fidel, Ph.D.

Stephen Lanier, Ph.D.Carol Mason, M.D.

Interdisciplinary

LSUHSC Research Council

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

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

Clinical Research in the HCSD

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

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

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

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.

Clinical Trials Office

LSUHSC Research Council

• 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.

Clinical Trials Office

These services are focused in five major areas:

1. Administrative

2. Regulatory Compliance

3. Specialized assistance with investigator initiated studies

4. Education/Training

5. Quality Control/Quality Assurance

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.

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.

Human Bio-specimen Core

LSUHSC Research Council

Advantages of a centralized Bio-Speciman Core

1. Organized and streamlined tissue procurement and distribution

2. Better catalouging and documentation of tissue and needs and availability

3. Avalaiblilty of both normal and diseased tissues

4. Easy access to tissues and blood samples

5. Uniform compliance with Institutional, State, Federal, and HHS Privacy rule regulations

6. Facilitation of translational research

7. Potential of more externally sponsored research

1. 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

Types of bio-specimens:

• 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)

Recommendations:

John Burgess, D.S.S.Kurt Varner, Ph.D.James Diaz, M.D.

Connie Romaine, RN, MNJudd Shellito, M.D.

Warren Summer, M.D. - Chairman

Education, Training and Mentoring

LSUHSC Research Council

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

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

John Estrada, M.D.Steve Nelson, M.D.

Augusto Ochoa, M.D. - Chairman

Incentives and Disincentives

LSUHSC Research Council

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

Incentives/Disincentives in Clinical Research: Recommendations

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