CCTSI Nuts and Bolts How the CCTSI Can Accelerate Your Research

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CCTSI Nuts and BoltsHow the CCTSI Can
Accelerate Your Research
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Schedule

• 1. Introduction Jane Reusch
• 2. PCIR Bob Eckel
• 3. Regulatory Angela Wishon
• 4. Biostatistics John Kittelson
• 5. Break out sessions
• 6. Summary of breakout and closing remarks

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Colorado Clinical Translational Sciences
Institute (CCTSI)

• Introduction to the
• Organization and Structure

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CCTSI at University of Colorado
President of University of Colorado
Affiliated Hospitals UCH, DH, TCH, NJH, KP,
DVAMC
Chancellor UCDenver
Chancellor UCBoulder
Vice Chancellor Of Research UCBoulder
Vice Chancellor Of Research UCDenver
Vice Chancellor Of Health Affairs UCDenver
UCBoulder Schools Colleges
Downtown Denver Campus Schools Colleges
School of Medicine
School of Pharmacy
College of Nursing
School of Dentistry
School of Public Health
Graduate School
Institutions Encompassed by the CCTSI
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CCTSI Organizational Structure
Chancellor of UCDHSC
Vice Chancellor of Research
Vice Chancellor of Health Affairs
Administrative Director/CFO
Administrative Core
CCTSI PI Director
CCTSI Executive Committee Director, 6
Co-Directors, CFO, Chair of IAC
CCTSl Advisory Council
Internal Advisory Committee
External Advisory Committee
Evaluation Center
6 Pillar Programs
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CCTSI Academic Home
Chancellor of UCDenver
Vice Chancellor of Research
Vice Chancellor of Health Affairs
Administrative Director / CFO
CCTSI PI and Director
Admin. Core
CCTSl Advisory Council
Internal Advisory Committee
CCTSI Executive Committee
External Advisory Committee
Evaluation Center
6 Pillar Programs
Translational Informatics Research Informatics
Integrated Core (RIIC)

• Education
• Training
• KL2, TL1 Clinical Faculty Scholars
• CLSC Career Development

Discovery Translation PCIR Design
Biostatistics Regulatory
Community Engagement Research
Novel Methods Technology CO-Pilot NeTT Novel
Methods
Child Maternal Health
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Discovery Translation Organization
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Workshop
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Education, Training, Career Development (ETCD)
Organization
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Case 1

• Jr. Faculty 1 has demonstrated that milk has
  the ability to cure lupus in mice. She would like
  to investigate this in humans. With her mentor,
  she has put together a set of specific aims and
  laid out a study design. Her mentor tells her to
  go to that new GCRC/CCTSI thing and get the
  project going. They have people there who can
  help you.

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Questions for Case 1

• Who are those people?
• How do you find them?
• How do you fill out the on-line application?
• What is the difference between the SARC and the
  IRB?
• Can you get someone to look over the
  application/project before you turn it in?
• How do you get help with statistics?
• Is there a course for this?

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PCIR Organizational Structure
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• New structure of the CTRCs (evolving see
  website)
• Centralized administration established
• Robert Eckel/Kristin Benn
• Tom Campbell / Pat Kittleson Adult CTRC
• Philip Zeitler/ Cindy Scott TCH CTRC
• Liz Connick/Mary Dang-UCB CTRC
• Donald Leong NJC CTRC
• Nursing TBA (outpt Lefevre inpt-Bilton)
• Bionutrition Janine Higgins
• Core Laboratories Bryan Haugen
• Streamlined centralized support services
• Centralized protocol submission process
• CTRC units and staff
• Bionutrition core
• Extended communication and services via the
  Nutrition Resource
• Core assay laboratories
• Bryan Haugen oversees consolidated core
  laboratory activities
• COMIRB approval only now possible

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• Design and implement the PCIR Central to support
  clinical and translational research for
  investigators
• New local scientific review process.
• New Scientific Advisory and Review Committees
  (SARC) established.
• Adult Wendy Kohrt, Ph.D and James Maloney, M.D.
  appointed as new co-chairs.
• Pediatrics Jeff Galinkin, M.D., Ph.D. and Paul
  Fennessey, Ph.D. retained as co-chairs.
• Protocol review process
• Expanded investigator support services the new
  CTO model
• In consideration, nothing implemented secondary
  to budget
• Integration with other institutional resources
• In progress (today)
• Matchmaker program
• In progress

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Case 2

• Jr. Faculty 2 has just been recruited to UCD and
  is going to be part of an NIH multicenter trial
  to examine exercise and drug X on breast cancer.
  He needs to get all the regulatory paperwork set
  up in order to participate. As far as he can
  tell, hes done a million online courses already.
  

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Questions for Case 2

• How does he find out what coursework is needed?
• Is there someone who can help with an IND?
• How does he register with clintrials.gov?
• Why is the consent form so complicated?
• How does he set up the contracts with the drug
  manufacturer?
• Is there a course for this?

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Regulatory Knowledge and Support Core

• Angela R. Charboneau Wishon, J.D.
• Assistant Vice Chancellor for Regulatory
  Compliance
• Director, CCTSI Regulatory Knowledge and Support
  Core

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Overall Goals for this Program/Core

• Provide academic medical researchers a resource
  to master the complexities of regulatory issues
  associated with translational research
• Enhance existing research support services by
  providing the infrastructure to efficiently
  manage the vast array of regulatory issues across
  the affiliated institutions within the region
  and
• Assure consistent standards of human protection
  within our affiliated institutions.

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Specific Aims in CTSA Grant

• Provide centralized services that facilitate
  preparation and maintenance of regulatory and
  administrative requirements and streamline
  researchers interactions with regulatory
  agencies.
• Provide centralized services that provide a
  clinical research quality assurance program.
• Provide consultative expertise and serve as a
  regulatory resource for researchers.
• Provide training and be a resource for education
  on regulatory topics.

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Organizational Structure
In process
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Case 3

• Jr. Faculty 3 is writing a grant proposal and
  has no clue where to start with the statistics
  section.

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Questions for Case 3

• How do you get help with a power analysis?
• Why would he want a statistician involved in the
  study before he has data?
• Does he just need statistical advice or does he
  need a statistician on the project?
• Is there a course for this?

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UCD Biostatistics and theBiostatistics,
Epidemiology, and Research Design (BERD) Program
of the CCTSI

• John Kittelson, PhD
• Monday October 12th, 2009

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Outline

• Overview of UCD Biostatistics
• Department of Biostatistics and Informatics
• Colorado Biostatistics Consortium (CBC)
• Research Institute (Pediatrics)
• Others
• BERD program
• Overview of infrastructure
• Education program
• Consultation/collaboration
• Methods development

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UCD Biostatistics Overview

• Department of Biostatistics and Informatics
• Research (biostatistics methods)
• Teaching
• Biostatistics graduate program (PhD, MS)
• Masters of Public Health
• Clinical Sciences Program

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UCD Biostatistics Overview

• Department of Biostatistics and Informatics
• Collaborations
• Cancer Center Pharmacy/pharmacology
• CAIANH COHO
• CHN BDC
• CFAR Psychiatry

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UCD Biostatistics Overview

• Colorado Biostatistics Consortium (CBC)
• A unit within the Department of Biostatistics
• Created to develop additional biostatistics
  resources and to prepare for CTSA application
• Funded through SIRC proposal
• 10 biostatisticians (including 4 from Pediatrics)

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UCD Biostatistics Overview

• Research Institute (Childrens Pediatrics)
• A unit within the Department of Pediatrics
• Collaborator in the CBC
• 4 biostatisticians
• Wide-ranging collaborations in pediatric research

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UCD Biostatistics Overview

• Others
• Department of Family Medicine
• Department of Anesthesiology
• Division of Health Care Policy Research

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BERD Program

• Biostatistics, Epidemiology, and Research Design
  (BERD) Program
• A collaboration across 10 groups
• Biostatistics Dept. Epidemiology Dept.
• Pediatrics Dept. COHO
• School of Pharmacy College of Nursing
• National Jewish CAIANH
• CO Prevention Center Kaiser Permanente

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Broad Objective To build breadth and depth
through collaboration
BERD Program
Epidemiol Dept
Pediatrics Dept
COHO
Pharmacy School
Biostatistics Department Colorado Biostatistics
Consortium CCTSI BERD Program
Family Medicine
Nursing College
Cancer Center
Statistics Dept
Psych Dept
National Jewish
CAIANH
Kaiser Perm
CFAR
CO Prevent Center
Human Nutrition Center
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Broad Objective To build breadth and depth
through collaboration
BERD Program
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Broad Objective To build breadth and depth
through collaboration
BERD Program
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Broad Objective To build breadth and depth
through collaboration
BERD Program
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BERD Program

• Education Program
• Biostatistics short courses for non-statisticians
• Data analysis short course
• Study design short course (in planning)
• Education seminar series
• (3-4pm last Monday of most months)
• Continuing education for biostatisticians
• Pharmacokinetic methods short course
• Workshop on non-inferiority trials
• Clinical trial design short course
• Note formal courses in Biostatistics Dept
• Bios 6601/6602 Biostatistics I/II
  (non-statisticians)
• Bios 6611/6612 Applied biostatistics
  (statisticians)
• Bios 6648 Clinical trials

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BERD Program

• Consultation/collaboration
• BERD program supports
• CCTSI Trainees (e.g., K-12 awardees)
• CCTSI pilot grant awardees
• CCTSI-supported studies on the CTRC
• Note limitations apply
• Process
• Register your project at http//cbc.uchsc.edu
• Statisticians meet weekly to review new work

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BERD Program

• New methods in translational statistics
• To advance the methodological aspects of
  translational research through original
  biostatistical methods research (including novel
  study design methods).

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• Recap of breakout results
• Closing