Clinical Investigation Research Laboratories - The Rest of

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D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Clinical Investigation Research Laboratories: The Rest of the Story

MAJ Jeremy L. Goodin Ph.D.

OIC, Clinical Investigation Laboratory

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Presentation Outline

I.

DCI Organization

II. Roles of DCI Officer-in-Charge (OIC)

III. Unique Capabilities

IV. DCI Comparison to Army Research Institutes

V. Conclusions

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Disclaimer

The content presented is the opinion of the author and does not reflect the views or policies of the U.S. Army. Mention of trade names, commercial products or organizations do not imply an endorsement by the U.S. government.

Common Sense - identifying particular items of knowledge as

"common sense" is difficult in the Army.

Perception - What one perceives is a result of interplays between past experiences, including one’s culture, and the interpretation of the perceived.

Relativism - the idea that some elements or aspects of experience or culture are relative to other elements or aspects. Humans can understand and evaluate beliefs and behaviors only in terms of their historical or cultural context.

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

DCI Mission

• Support graduate and continuing medical education

• Provide guidance and support for research

• Provide an academic milieu conducive to retention and recruitment of personnel

• Foster an atmosphere of inquiry

• Provide a review body for evaluation of research proposals

• Promote the highest level of professional standards in the conduct of human and animal research

Research, Education and Training for the Advancement of Military Medicine

Red = vacant

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Department of Clinical Investigation

Research Administration Section

DDEAMC, Fort Gordon GA 30905

Phone: 706-787-5384

Department of Clinical Investigation

Research Laboratory and Education Section

BLDG 38705 Fort Gordon GA 30905

Phone: 706-787-0006

Chief, DCI

Secretary

Human Protections Admin

Clinical Research Protocol Administrative

Processing Section

Case Manager

Protocol Coordinator x 2

Assistant Chief Dept/Lab Manager

DCI Research and Training Laboratory

OIC-71B

NCOIC-E6

NCO-E5

Human Use Section

IRB Function

Animal Use Section

IACUC Function

Molecular Biology Section

Staff Scientist Ph.D.

Research Tech

Microbiology Section

CPT-71A

Biomedical Eng

Publication Review and

Clearance Section

Regulatory Assurance and

Regulated Studies Section

Physiology and Cellular

Biology Section

Staff Scientist Ph.D.

Staff Scientist, Ph.D.

Laboratory Animal Support

Veterinarian-DVM

Animal Tech x 3

Research, Education and Training for the Advancement of Military Medicine

2Q FY 2010

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Additional Personnel

Contract Personnel

3-5 Research Assistants/Technicians

1 Biomedical Engineer

1 Statistician

1 Veterinarian

1-2 Assistant Protocol Coordinators

Residents

3 full time surgery residents

3-6 additional medical residents

4-6 dental residents

Volunteer Personnel

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

OIC Primary Duties

• Supervision and comprehensive management of the EAMC Clinical

Investigation Research Facility.

• Responsible for successful execution of the DCI mission: multidisciplinary military-relevant research, education and training programs.

• Rate or senior rate civilian and military personnel.

• Serve as senior military research scientist, principle investigator and subject matter expert for the medical and dental residency programs.

• Supervise the development of all clinical investigation research projects

• Serve as Chair, Institutional Animal Care and Use Committee (IACUC).

• Serve as acting DCI Chief as needed.

• Serve as Contracting Officer’s Representative for multiple contracts.

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

DCI Research Mission

Unique Capabilities

Research, Education and Training for the Advancement of Military Medicine

Specialized Equipment

•Quantitative Real-time PCR

•Microarrays

•Immunohistochemistry

•Instron materials testing

•Confocal/Fluorescent

Microscopy

•Kodak In-vivo FX Imager

•Faxitron X-ray Imager

•SEM Electron Microscope

•HPLC

•ELISA

•Nanodrop Spectrophotometry

•In-house Vivarium

•Surgical Suite

Laser Capture Microdissection System

• Allows for isolation of specific cells of interest from thin tissue sections

• Very useful for collection of specific cell types for

DNA, RNA or protein analysis

Breast Duct Epithelial Cells Modular Stage

Whitley MG500 Anaerobic Workstation

JSM Scanning Electron Microscope

Bone Chip

2000X

Disk

Instron 4502 Mechanical Strain

Analysis System

Application areas:

• Tensile strength testing

• Compressive strength testing

• Fatigue testing

• Flexural strength testing

• Impact force testing

DCI testing has involved:

• Adhesive Sutures

• Resorbable Screws

• External Fixatures

Research Vivarium and Surgical Suite

Animal models of human disease

Training labs for procedures, surgeries

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Comparison of MEDCEN Clinical Investigation to

U.S. Army Research Institutes

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

METT-TC based comparison of U.S. Army Research

Institutes to U.S. Army Clinical Investigation Laboratory

Mission

Enemy

Terrain and Weather

Troops and Support

Time

Civil Considerations

Research, Education and Training for the Advancement of Military Medicine

METT-TC: Mission

Research Institute

Research is the focus

Funding driven, salaries directly tied to research proposals

Applied science,

Product oriented,

Milestone driven

Clinical Investigation

Patient care is the priority

Less emphasis on funding, salaries part of hospital budget

Basic science,

Product oriented, but the products are education and training

© Jeff Jones 2010

Research Institute

Bureaucracy

Bureaucracy

Bureaucracy

Bureaucracy

Bureaucracy

METT-TC: Enemy

Clinical Investigation

Bureaucracy

Bureaucracy

Bureaucracy

Bureaucracy is the collective organizational structure, procedures, protocols, and set of regulations in place to manage activity.

METT-TC: Terrain and Weather

Research Institute

Similar to Industry

Very tight security

Clinical Investigation

Similar to Academia

Much less stringent security

© Jeff Jones 2010

METT-TC: Troops and Support

Research Institute

~300-700 total workforce

~50-100 military

All personnel and support focused on

Research as the primary mission

Clinical Investigation

~3,000 total workforce

~1,000 military

DCI personnel focused on Research,

Education and Training

Hospital support personnel turn around time can sometimes be slow

METT-TC: Time

Research Institute Clinical Investigation

Many “hard” deadlines and suspense dates due to funding cycles

~75% of time available to conduct research if in “investigator” position

~0% of time available to conduct research if in management or staff officer position

Some deadlines - residents have time constraints

~40% of time available to conduct research in OIC position

METT-TC: Civil Considerations

Research Institute

Majority of workforce are civilian and contractor

Civilian personnel issues may require a great deal of time and energy

Civilian’s have added pressure of competitive funding

Clinical Investigation

Majority of workforce are civilian and contractor

Civilian personnel issues may require a great deal of time and energy

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Mentorship

Rater Senior Rater Location

Service School

RIID-2003

(120 Day OER)

RIID-2004

RIID-2004

Service School

RIID-2006

MRICD-2007

MRICD-2008

MRICD-2009

MRICD-2009

EAMC-2010

71A-LTC (Microbiology)

DB3-Civilian (Scientist)

DB4-Civilian (Scientist)

71A-LTC

71A-LTC

71A-LTC

DB4-Civilian (Scientist)

71A-LTC (Microbiology)

64D-LTC (Veterinarian)

71A-LTC

71B-COL (Dep CDR)

71B-COL (Dep CDR)

SES-Civilian (Operations) 64C-COL (Dep CDR)

GS14-Civilian (Operations) 64C-COL (Dep CDR)

YG3-Civilian (Physician) 61F-COL (Dep CDR)

(Physician)

Research, Education and Training for the Advancement of Military Medicine

D.D. Eisenhower Army Medical Center Department of Clinical Investigation

Questions?

MAJ Jeremy L. Goodin Ph.D.

OIC, Clinical Investigation Laboratory

Research, Education and Training for the Advancement of Military Medicine

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