The New General Clinical Research Center

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The New General Clinical Research Center

• Robert Sherwin, MD
• C.N.H. Long Professor of Medicine
• GCRC Program Director

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The Yale GCRC Early History
Founded in 1960 by Dr. Paul Beeson the
original grant was 5 of the current proposal
1960s - GCRC Adult Unit opened on Hunter 5 and
the Childrens Unit was based on Fitkin 3.
1980s - the Childrens Unit moved to 7-4
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The Yale GCRC 45 Years of Scientific
Accomplishments
Diabetes Mellitus Mineral Metabolism Genetics of
Hypertension Obesity Fuel Metabolism Drug
Dependence Child Psychiatry Rheumatology Cancer
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Adult Childrens Unit Changes Challenges
2000 Adult GCRC moved to East Pavilion 10-5/6
2001 Adult GCRC Site Visit Approval, but
with 3 yrs reduced funding
2003 Childrens CRC Site Visit
NIH mandated merger of the childrens and adults
GCRC as a per diem Unit with a 1 million budget
reduction to take effect in 2 months
Our Response Build a NEW GCRC
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Building A New GCRC
Short-term Strategic Plan To make fundamental
changes in the structure, leadership, and
organization of the GCRC.

• Create a new administrative structure
• Successfully implement the merger

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Organizational Structure The New Team
Robert Alpern MD GCRC Principal Investigator
Peter Herbert MD GAC Chair
Penny Cook Deans Liaison to GCRC
Rosa Hendler MD RSA
Robert Sherwin MD Director
T. Carpenter MD RSA Pediatrics
William Tamborlane, MD Deputy Director for
Pediatric Research
Tahiry Sanchez RN, MS Nursing Director
Core Resources
Core Resources
Harlan Krumholz MD, Training Development
Barbara Gulanski MD, MPHAsst. Director,
Operations Study Recruitment
James Leckman MD Assoc. Director Child Study
Ctr.
Sonja Beamon Administrative Director
D. Rothman PhD Asst. Director MRRC
Perry Miller MD, PhD Core Director
Li Wen MD, PhD Core Director Core Lab
Sonja Beamon Administrative Director
Perry Miller MD, PhD, Informatics Core Director
D. Rothman PhD Asst. Director MRRC
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Reorganization Timeline
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The Post Site Visit Results


The site visit team judged the merger a
remarkable success Priority Score1.47!


In short, we believe the new GCRC is much greater
than the sum of its parts.
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The Current GCRC
120 Protocols
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The Current GCRC
Obstetrics /Gynecology Adult Psychology Child
Psychology Neonatology Pedi. Endocrinology General
Pediatrics Diagnostic Radiology/MR Rheumatology G
enetics Endocrinology Infectious Diseases Pedi.
Anesthesiology Cardiology Pedi. Surgery Pedi.
Neurology Occupational Health
120 Protocols
17 Sections/Departments
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The Current GCRC
120 Protocols
17 Sections/Departments

• 66 Principal Investigators

• School of Medicine (61)
• School of Nursing (1)
• School of Epi. Public Health (4)

23 Young Investigators
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The Current GCRC
120 Protocols
17 Sections/Departments

• 66 Principal Investigators

• School of Medicine (61)
• School of Nursing (1)
• School of Epi. Public Health (4)

23 Young Investigators
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GCRC Changes

• OLD GCRC

NEW GCRC
Adults Hunter 5 Endo/Psych focused Localized
Combined Adult Childrens Unit East Pavilion
10-5/10-6 Increased Diversity Many Off-Site
Resources
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Major GCRC Off-Site Resources for Clinical
Research
The Yale Center for Medical Informatics (GCRC
Core)
Keck Biotechnology Resource Lab (New Genomics
Core)
Recently renovated GCRC Core Laboratory
General Clinical Research Center
Community-based Research Nurse
Yale Child Study Center (GCRC Nurse)
Inpatient Outpatient Services on 10-6 10-5
Magnetic Resonance Research Center (GCRC Core)
Clinical Neuroscience Research Unit at CMHC (GCRC
Nurse)
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Building A New GCRC



Long-Term Strategic Plan Create a fresh vision
of our research mission
1. To establish the GCRC as the central resource
for clinical research at Yale by more effectively
leveraging the medical centers world-class
resources. 2. To accomplish this, we will build
upon our traditional strengths and create new
research and training opportunities fostering
more diverse and interdisciplinary clinical
science.
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New Initiatives

• Magnetic Resonance Center Resource Core
• Community-based Research Nurse
• Diversify Core Lab and establish Genomics Core
  Resource
• Create a New Training Model

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Goals of the MR Core

• Facilitate and increase GCRC usage by assisting
  investigators in the design of protocols using MR
• Support costs for GCRC investigators by funding
  MRRC research staff and blood processing
• Provide nursing support for protocols and for
  enhancing patient safety

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MRRC Support Facilities

• Fully equipped recovery room with 2 patient beds
• Three patient interview rooms equipped for
  physiological monitoring and psychological
  testing
• Mock scanner to acclimate subjects for MR studies
• Blood processing room to support stable isotope
  and hormone infusion studies
• State-of-the-art scanners for fMRI, spectroscopy,
  and brain anatomy

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4T Human MRS/MRI System
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Community Based Nursing
APT
School-Based Protocols
Community Based Nursing Program
Hill Health Center
Fair Haven Community Health Center
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Diversify Laboratory Services
Past Core Lab Analyses Offered RIA, HPLC,
Biochemical Substrate Measurements
Newly Expanded Proposed Services ELISA Genomics
Core
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ELISA
Hepcidin IL-6 TNFa IL-6sr IL-11
RANK ligand TGFb
Fibronectin IL-1b NTX ICAM
VCAM OPT
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Proposed GCRC Genomics Core Will Be Located
Within 2 of the 12 Keck Lab Resources

• Affymetrix GeneChip
• mRNA Expression
• Quantitative PCR
• SNP Genotyping
• Biostatistical Resource for analysis of genomics
  studies

Cluster Analysis of DNA Microarray Data
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Proposed Genomics Core will Leverage Keck
Laboratory Technologies

• Subsidize service charges paid by GCRC users of
  the Keck Affymetrix and Biostatistics Resources
• Support user training workshops, seminars, and
  one-on-one training by Keck staff
• Upgrade computer workstations for analyzing mRNA
  expression and SNP genotyping data

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Vision The GCRC Training Program
Director Harlan Krumholtz

• GCRC as an institutional center of gravity for
  training and education in clinical investigation
• Promote communication/coordination
• Increase synergy among federally funded training
  efforts

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Training Proposed Initiatives

• Fill gaps in curricular content content by
  focusing on practical issues related to human
  investigation, e.g. IRB, HIPAA, ethics
• Support grant applications by creating a
  repository of successful grants, including K
  awards
• K23 Preparation Lecture Series

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The New General Clinical Research Center

• Barbara Gulanski, MD, MPH
• Asst. Professor of Medicine (Endocrine)
• GCRC Asst. Program Director, Operations

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Available GCRC Resources

• Research Facility
• Research Nursing
• Informatics Core
• Biostatistics Core
• Bionutrition
• Core Lab support
• Pilot and feasibility funding (CReFF)

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GCRC Research Facilities

• 7,069 sq. ft. of research space located on 10-6
  in the East Pavilion
• 11 beds available for outpatient or inpatient
  studies
• Additional 2 rooms available for administering
  questionnaires, obtaining informed consent,
  subject training
• Laboratory for processing lab samples
• Waiting area for study subjects
• Equipment Delta-trac, DXA scanner, point-of-care
  glucose measures,

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GCRC Research Facilities
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Blood Processing Lab
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Research Nursing

• 10 on-site nurses with extensive research skills
  and experience
• Infusions, chemotherapy, ecgs, stable
  isotopes, insulin clamps, anthropometrics,
  pK studies, microdialysis studies, etc
• 3 PCAs (Patient Care Associates)
• Pediatric and adult competencies
• Assist with implementation of studies
• Expansion to off-site facilities, e.g., YNHH and
  community

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Bionutrition Core

• Two registered Dieticians with extensive
  experience in nutritional studies
• Support for protocol design for nutrition studies
• Design of research diets
• Anthropometrics
• Nutrition assessment and counseling
• Dietary data collection
• Metabolic Kitchen for preparation of research
  diets

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Metabolic Kitchen
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Core Resources

• Informatics and Biostatistics
• Core Lab
• Proposed Keck Genomics Core

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Informatics

• Mission To facilitate and promote clinical
  research by providing consultation, assistance,
  and direction to data acquisition, storage,
  retrieval and management
• Provides data management support with a variety
  of database packages
• Trial/DB is a secure, flexible, powerful
  web-accessible database designed to support
  clinical trials

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Biostatistics
GCRC Biostatistician James Dziura, PhD

• Biostatisicial Core provides
• Consultation in study design, data management and
  data analysis for GCRC investigators
• Review of all incoming protocols to insure sound
  biostatistical plan
• Training in statistical design and analysis
• We hope to support data management and
  biostatistical analysis for genomics studies
  through the Yale Microarray Database and Keck
  Biostatistical Resource

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Purpose of GCRC Core Laboratory

• To provide
• specialized biological and biochemical assays to
  support GCRC investigators

cost effective
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Core Lab Structure
Sample Processing Unit
ACTH, C-peptide, ghrelin, growth hormone,
insulin, adiponectin, cortisol, leptin, IGF1,
prolactin, vitamin D
Catecholamines, free amino acids
Glucose, ketones, hsCRP, lipids, free fatty acids
IL-6, TNF?, ICAM, VCAM, IL-11, NTX, TGF?
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CReFF Program

• Clinical Research Feasibility Funds (CReFF)
• To provide seed money for young investigators
  interested in patient oriented research project
• Provides 20K over one year in direct costs
• In 2004, three awards were given
• Kristina Crothers, MD Internal Med/Pulmonary
• Peter Morgan, MD Psychiatry
• Shawn Cowpers, MD Dermatopathology

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How to get your study approved for utilization of
GCRC resources
General Advisory Committee (GAC) approval process

• All studies require GAC approval in order to
  utilize GCRC resources
• GAC membership Peter Herbert MD (GAC Chair) and
  15 faculty members from across the Medical School
  meet monthly to review new protocols
• Please call us to discuss your study before
  submitting to HIC
• Applications can be obtained by calling us or via
  the website

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GAC Review Process
INVESTIGATOR
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How to get started

• Main phone [phone]
• Website http//info.med.yale.edu/gcrc

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In Summary

• The Yale GCRC has the resources to support
  peer-reviewed funded human-based research at
  Yale.
• The GCRC merger has been remarkably successful.
• The new leadership is working to
• - Responsibly use its diverse resources
• - Improve the protocol review process
• - Streamline

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In Summary

• A more effective HIC/GCRC relationship has
  improved patient safety and consent procedures.
• New initiatives and partnerships have been
  created to
• - Increase scientific diversity
• - Provide new scientific resources
• - Develop new training programs
• - Support research opportunities for
  young invesigators through pilot grants