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Introduction to Clinical Investigation Role of the General Clinical Research Center (GCRC) in Clinical Research October

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 Investigation Role of the General Clinical Research Center (GCRC) in Clinical Research October

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

  2. 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.”

  3. 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

  4. 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

  5. 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

  6. 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

  7. DiversityUVA GCRC: New “A” Protocols by Theme * Diabetes, Neurology, Cystic Fibrosis, G.I.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. The Biostatistics Core II. • Reviews all protocols submitted to the GCRC Advisory Committee • Contributes to training through coursework, tutorials and symposia focussed on biostatistics

  16. 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

  17. 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

  18. 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

  19. 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

  20. Training in Clinical Investigation An optimal training program would include: • practical, hands-on experience • appropriate didactic work • mentoring

  21. 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

  22. 1997 HES GCRC Master’s Program in Health Evaluation Sciences Multidisciplinary Training Program in Clinical Investigation (MTPCI)

  23. 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

  24. 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

  25. 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

  26. Grant Preparation Resources I.

  27. 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

  28. GCRC Protocol Preparation and Review I. TITLE PI CO-PI HYPOTHESIS BACKGROUND

  29. GCRC Protocol Preparation and Review II. METHODOLOGY Procedures Biostatistical Analysis Analytical Methods Investigational Drugs

  30. GCRC Protocol Preparation and Review III. HUMAN SUBJECTS Characteristics Special Notes: women/minorities Criteria for inclusion/exclusion Special classes Source of research material

  31. GCRC Protocol Preparation and Review IV. HUMAN SUBJECTS Recruitment IRB Risks Alternatives Protections Risk/benefit

  32. 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

  33. 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

  34. The Review Process Advisory Committee votes on protocol Protocol disapproved or tabled Protocol approved Concerns appropriately addressed by PI Protocol withdrawn Protocol initiated

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