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Introduction to Clinical Investigation Role of the General Clinical Research Center (GCRC) in Clinical Research October 18, 2005. The General Clinical Research Center.

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Introduction to Clinical InvestigationRole of the General Clinical Research Center (GCRC) in Clinical ResearchOctober 18, 2005

the general clinical research center
The General Clinical Research Center

“…dedicated to the advancement of scientific investigation of normal and abnormal human physiology with the goal of advancing knowledge of causes, prevention, control and cure of human diseases.”

about the gcrc s
About the GCRC’s...
  • There are 78 GCRC’s nationwide, all supported by the National Institutes of Health
  • The GCRC’s are funded for up to five years with a competitive renewal required
  • The UVA GCRC will receive $22,030,026 in funding during our current 5 year renewal
the university of virginia gcrc
The University of Virginia GCRC
  • Serves as a laboratory in which to conduct clinical investigation
  • Provides both practical and didactic education opportunities for M.D.’s and Ph.D.’s interested in clinical investigation
the uva gcrc consists of
The UVA GCRC Consists of:
  • 10 inpatient beds
  • outpatient facilities
  • a Metabolic Kitchen
  • a research nurse staff functioning 24/7
  • a Core Assay Laboratory
  • an Informatics Core
  • a Biostatistical Core
  • a Biomathematics Core
  • an Exercise Physiology Laboratory
  • a Sleep-Monitoring Laboratory
gcrc protocols
GCRC Protocols

A: Investigator-initiated, “pure research” studies; subjects/patients admitted solely for purpose of participating in the research study

B: Investigator-initiated studies utilizing patients admitted to hospital for medical care

D: Industry-initiated or sponsored studies; sponsor pays expenses

diversity uva gcrc new a protocols by theme
DiversityUVA GCRC: New “A” Protocols by Theme

* Diabetes, Neurology,

Cystic Fibrosis, G.I.

gcrc administrative structure
GCRC: Administrative Structure

Principal Investigator: Arthur “Tim” Garson, M.D., M.P.H.

Program Director: Eugene J. Barrett, M.D., Ph.D.

Associate Program Directors:

William S. Evans, M.D.

Dan Haisenleder, Ph.D.

Mary Lee Vance, M.D.

Administrator: Pamela F. Sprouse

gcrc nursing services
GCRC Nursing Services

Nursing Coordinator: Sandra Ware-Jackson, R.N.

  • Provide technical support and clinical care to subjects and patients participating in both inpatient and outpatient protocols
  • Act as primary contact between PI and subjects/patients
gcrc assay core laboratory i
GCRC Assay Core Laboratory I.

Director: Dan Haisenleder, Ph.D.

Manager: Pattie Hellmann

Technicians: David Smith, Sally Rittenhouse

…..to provide cost-effective assay services to GCRC investigators with exemplary quality assurance

gcrc assay core laboratory ii
GCRC Assay Core Laboratory II.

Services offered by the laboratory:

  • Immunoradiometric, immunoflurometric, chemiluminescent, and Elisa assays of 40 individual substances
  • Automated data management
  • Development of new assays as needed by investigators
the metabolic kitchen
The Metabolic Kitchen

Dietitian:Jessica Rodriguez, R.D.

Chefs: Rick Friend, Dornita Herndon, Vanda Mattysse

  • Develops and prepares metabolically-balanced, controlled nutrient research diets for protocol subjects
  • Provides software for analysis of nutrient intake
  • Instructs subjects in specialized diets
the informatics core
The Informatics Core

Informatics Manager: Martin T. Phillips, B.S.

  • Provides investigators with computer tools to facilitate analysis/publication of research data
  • Networks with other UVA GCRC Cores
  • Facilitates interactions among research centers including other GCRCs.
the biostatistics core i
The Biostatistics Core I.

Biostatisticians: RD Abbott, Ph.D., DG Boyd, M.S.,

JT Patrie, M.S.

  • Assists in protocol development by:
    • Helping to formulate hypotheses that can be analyzed statistically
    • Identifying experimental designs and efficient statistical procedures
    • Recommending sample size
    • Analyzing data
    • Interpreting statistical results for clinical investigation
the biostatistics core ii
The Biostatistics Core II.
  • Reviews all protocols submitted to the GCRC Advisory Committee
  • Contributes to training through coursework, tutorials and symposia focussed on biostatistics
the biomathematics core
The Biomathematics Core

Biomathematician: Michael L. Johnson, Ph.D.

  • Provides support to address biological issues using advanced mathematical approaches
  • Develops/modifies specific biomathematical techniques such as:

-Cluster -Pulse -HyperGeo -Cross ApEn

-Deconv -Pulse2 -ApEn

  • Organizes an annual workshop for clinical investigators interested in applying sophisticated mathematical approaches to biologic questions
the exercise physiology laboratory i
The Exercise Physiology Laboratory I.

Director: Arthur L. Weltman, Ph.D.

  • Provides consultation regarding protocol development and training of investigators interested in exercise physiology techniques
the exercise physiology laboratory ii
The Exercise Physiology Laboratory II.
  • Provides support for procedures related to:
    • exercise (e.g., training and evaluation)
    • metabolism (e.g., calorimetry)
    • body composition (hydrostatics weighing; DEXA; bioelectrical impedance)
    • strength/balance function
the sleep research laboratory
The Sleep Research Laboratory

Director: Paul M. Suratt, M.D.

  • Provides consultation for protocol development for investigators interested in monitoring subjects during sleep
  • Provides monitoring of sleep stages, breathing, ECG and other physiological signals during sleep
  • Provides integration of sleep stages with other parameters such as hormone secretion during sleep
  • Provides interpretation of data collected using the above techniques
training in clinical investigation
Training in Clinical Investigation

An optimal training program would include:

  • practical, hands-on experience
  • appropriate didactic work
  • mentoring
approaches to the training of clinical investigators
Approaches to the Training of Clinical Investigators:
  • Highly structured, thesis-requiring graduate programs resulting in the granting of a Master’s Degree or Ph.D.
  • Relatively flexible, non-degree granting programs with emphasis on highly relevant didactic work and mentoring
slide22
1997

HES

GCRC

Master’s Program in

Health Evaluation Sciences

Multidisciplinary Training Program in Clinical Investigation (MTPCI)

1997 multidisciplinary training program in clinical investigation mtpci
1997: Multidisciplinary Training Program in Clinical Investigation (MTPCI)
  • Targets senior fellows and junior faculty
  • No tuition required
  • 3-6 year part-time training effort
  • Emphasis on grant submissions & peer-reviewed publications rather than a thesis
  • Certficate in Clinical Investigation awarded upon successful completion of program requirements
  • Acquisition of grant support is a major objective
the didactic program
The Didactic Program

Required Core Courses:

Introduction to Clinical Investigation

Introduction to Biostatistics

Fundamentals of Epidemiology

Research Ethics

Elective Courses:

Chosen with guidance from the trainee’s Mentoring Committee from any school within the University of Virginia

the mentoring process
The Mentoring Process
  • Each trainee has a committee comprising 3 senior faculty members, each of whom “brings something to the table”
  • The full committee & trainee meet twice a year
  • Structure of the meeting:
    • Goals & objectives from the last mentoring are reviewed
    • Progress since last mentoring is discussed
    • Goals & objectives for the next six months are agreed upon including specific coursework recommendations
  • Formal summary report is generated
  • The trainee schedules a post-mentoring session review with the Program Director
grant preparation resources ii
Grant Preparation Resources II.
  • Grant-specific notebooks contain:
    • NIH and University forms and instructions
    • completed applications from UVa funded grants to serve as examples.
  • Collection includes K-01, K-08, K-23, K-24, K-25 and F-32
gcrc protocol preparation and review i
GCRC Protocol Preparation and Review I.

TITLE

PI

CO-PI

HYPOTHESIS

BACKGROUND

gcrc protocol preparation and review ii
GCRC Protocol Preparation and Review II.

METHODOLOGY

Procedures

Biostatistical Analysis

Analytical Methods

Investigational Drugs

gcrc protocol preparation and review iii
GCRC Protocol Preparation and Review III.

HUMAN SUBJECTS

Characteristics

Special Notes: women/minorities

Criteria for inclusion/exclusion

Special classes

Source of research material

gcrc protocol preparation and review iv
GCRC Protocol Preparation and Review IV.

HUMAN SUBJECTS

Recruitment

IRB

Risks

Alternatives

Protections

Risk/benefit

gcrc protocol preparation and review v
GCRC Protocol Preparation and Review V.

GCRC UTILIZATION

Justification

Numbers of patients/days

Resource use

Bibliography:

In support of current work

Previous work by PI

SUMMARY SHEET

the review process
The Review Process

Protocol sent to GCRC

Assigned to a primary and secondary reviewer

Reviewers discuss their thoughts, concerns with PI and send reviews to GCRC Advisory Committee

PI meets with Advisory Committee to address concerns raised by reviewers

the review process1
The Review Process

Advisory Committee votes on protocol

Protocol disapproved or tabled

Protocol approved

Concerns appropriately addressed by PI

Protocol withdrawn

Protocol initiated