Johns Hopkins Institute for
Clinical and Translational Research
A CTSA Program
Daniel E. Ford, M.D., M.P.H.
Director, Institute for Clinical and
Translational Research
Vice Dean for Clinical Investigation
Goals for the Presentation
• Introduce national and local CTSA
program
• Describe plans for IT support of clinical
research
• Give us advice on how to transform clinical
and translational research at Johns
Hopkins
Impetus for the CTSA Program
 Implementing biomedical discoveries
made in the last 10 years demands an
evolution of clinical science.
 New prevention strategies and
treatments must be developed, tested,
and brought into medical practice more
rapidly.
 CTSA awards will lower barriers
between disciplines, and encourage
creative, innovative approaches to solve
complex medical problems.
 These clinical and translational science
awards will catalyze change -- breaking
silos, breaking barriers, and breaking
conventions.
Urgency to Change at Johns Hopkins
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Faculty want more training and resources in translational research
Regulatory environment more complex
Not enough trained specialists in translational research (staff and faculty)
Basic scientists cannot easily find clinical research collaborators
Competition from both community hospitals/physician and international
sites
Need to preserve academic reputation of Johns Hopkins
Accrual of research participants too slow
Lack of centralized informatics support
No institutional biospecimen bank
Not certain what our role should be in investigator-initiated research as
compared to big science (shared data/multicenter)
NIH support is flat and need to show leveraging of resources
Building a National CTSA Consortium
WA
MT
ME
ND
VT
MN
OR
ID
WI
SD
NH
MA
NY
WY
RI
MI
IA
NE
NV
PA
OH
IL
UT
DE
IN
CO
MD
WV
KS
CA
MO
VA
KY
TN
AZ
NJ
OK
NM
AR
SC
MS
AL
GA
TX
LA
AK
FL
HI
Participating Institutions
Since 2006
Since 2007
CT
Building a National CTSA Consortium
FY06 Grantees
Center for Clinical and Translational Science
The Rockefeller University
Center for Clinical and Translational Sciences
University of Texas Health Sciences Center at Houston
Clinical and Translational Science Center
University of California, Davis
Clinical and Translational Science Institute
University of Pittsburgh
Clinical and Translational Science Institute
University of California, San Francisco
Clinical and Translational Sciences Institute
University of Rochester School of Medicine and Dentistry
FY07 Grantees
Atlanta Clinical and Translational Science Institute
Emory University (partnering with Morehouse College)
CTSA at Case Western University
Case Western University
CTSA at Washington University
Washington University
CTSA at Weill Cornell Medical College
Weill Cornell Medical College (partnering with Hunter College)
Institute for Clinical and Translational Research
University Of Wisconsin Madison
Institute for Clinical and Translational Research
Johns Hopkins
Duke Clinical and Translational Science Institute
Duke University
Institute of Translational Health Sciences
University Of Washington
Institute for Translational Medicine and Therapeutics
University of Pennsylvania
Irving Institute for Clinical and Translational Research
Columbia University
Mayo Center for Translational Science Activities
Mayo Clinic
Oregon Clinical and Translational Research Institute
Oregon Health and Science University (partnering with
Kaiser Permanente)
Yale Center for Clinical Investigation
Yale University
Michigan Institute of Clinical and Health Research
University Of Michigan At Ann Arbor
North & Central Texas Clinical and Translational Science
Initiative
University of Texas Southwestern Medical Center - Dallas
University Of Chicago CTSA
University Of Chicago
Univ of Iowa's Inst for Clinical and Translational Science
University Of Iowa
Vanderbilt Institute for Clinical and Translational Research
Vanderbilt University (partnering with Meharry Medical College)
CTSAWeb.org
Consortium Governance & Organization
Governance Manual available at
http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf
Translational Pathway
Basic
Discovery
Mechanistic
Studies
Initial
Human
Testing
1
Proof of
Efficacy
Proof of
Effectiveness
2
Diffusion to
All Health
Care
Settings
Institute for Clinical and Translational Research
Influence on Scientific Discovery
Research Education and Training
Enhancing
Observation
Formulation of
Scientific Question
Advisory Boards
Protocol Review
Translational Science Forums
Science Cores
Innovation Groups
Biostatistical Support
Regulatory Support
ATIP
Research Ethics
Clinical Research Units
Clinical Research Participant Core
Data/Safety Monitoring
Community Engagement Program
Biomedical Informatics
Navigator Program
Creation of
Research Team
Development
Study Protocol
Conduct
of Study
Analysis of
Study Data
Publication
Impact Study
Johns Hopkins Programs Before CTSA
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K12 Clinical Research Scholars Program
Graduate Training in Clinical Investigation
T32 Medical Student Training Program
Johns Hopkins GCRC
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Inpatient
Outpatient
Pediatric
Kennedy-Krieger Neurobehavioral Research Unit
• Bayview GCRC
Johns Hopkins Institute for Clinical
and Translational Research
Research participant
Recruitment office
Trial Design
Advanced
Degree-Granting
Programs
Biomedical
Informatics
Johns Hopkins
ICTR
Clinical
Resources
Biostatistics
NIH & other
government
agencies
Industry
Participant
& Community
Involvement
Regulatory
Support
Healthcare
organizations
Institute for
Clinical and Translational Research
• Goals
– Academic Home for Clinical and Translational Researchers
– Coordinate Translational Research Activities
– Support Training of Clinical and Translational Research Faculty
and Staff
– Provide centralized support for research where efficient
– Measure and track efficiency of research to address barriers
• Director – Daniel Ford, MD, MPH Vice Dean for Clinical
Investigation
• Location – Small Office at Thames Street
Deputy Directors of the Institute for
Clinical and Translational Research
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Dr. Charles Balch
Dr. Stephen Desiderio
Dr. Elizabeth Jaffee
Dr. Pamela Ouyang
Dr. Neil Powe
Dr. Christopher Saudek
Dr. Pamela Zeitlin
Johns Hopkins ICTR
Participating Schools
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School of Engineering
School of Medicine
School of Nursing
School of Public Health
Research Education, Training, and
Career Development
Leaders: Neil Powe, Franklin Adkinson, Susan Furth,
Edgar Miller, Jon Samet, Scott Zeger,
Jennifer Haythornwaite, Jeri Allen and
Charles Flexner
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Coordinates clinical and translational research training throughout Johns
Hopkins
Administers formal degree granting programs in clinical research (Graduate
Program in Clinical Investigation, Clinical Epidemiology Program)
Administers predoctoral (TL), postdoctoral (KL) and junior faculty (KL)
training awards in clinical and translational research
Coordinates summer and elective experiences in clinical and translational
research for medical students
Curriculum design, innovation and development of problem/case and/or
team based modules in clinical research
Coordinates clinical research curriculum for medical students across the
four years of medical school
Provides technical assistance on study design, study implementation, data
collection, data management and data analysis to clinical and translational
research trainees in the formal program
Basic Science Translational Forum
Leaders: Stephen Desiderio and Elizabeth
Jaffee
• Identify basic science researchers who are considering
translation to human biology and/or clinical settings
• Identify clinical investigators who wish to collaborate with
basic scientists to develop or improve tools for clinical
research
• Match each of these groups with appropriate clinical or
basic research faculty
• Nurture groups through facilitated access to experts and
institutional resources
• Conduct formal follow-up to evaluate effectiveness
Clinical Science Translational Forum
Leaders: Daniel Ford and Peter Pronovost
• Identify clinical researchers who are considering
translation to broader community – knowledge transfer
• Match these groups with appropriate basic research
faculty, community populations, providers and payers
• Nurture groups through facilitated access to content
experts and institutional resources
• Conduct formal follow-up to evaluate effectiveness
Clinical Research Units
Leaders: Pamela Ouyang (Bayview), Christopher Saudek (JHH Broadway),
Pamela Zeitlin (Pediatrics), Michael Cataldo (Neurobehavioral KKI)
• Continue to provide the “laboratory” in which over 260 active clinical
research protocols currently being accomplished
• Inpatient and Outpatient facilities on the Broadway and Bayview
campuses (both adult and pediatric); sleep units (Pediatric at Broadway,
Adult at the Bayview campus)
• Emphasis on investigator-initiated protocols
• Provide thorough peer review prior to study initiation
• Support investigators with trained research nurses, phlebotomists, and
interviewers
• Support investigators with computing (including system manager), full
nutrition staff and consultations.
• Support investigators by funding limited laboratory and imaging costs as
Ancillaries
Clinical Research Units
• Provide specialized services such as exercise
(Bayview/GSS), body composition, CV imaging
(Bayview), and a Core Laboratory for research
immunoassays, mucociliary clearance laboratory, flexible
bronchoscopy, BAL and infant lung function laboratory
(Pediatrics)
• Provide specimen processing
• Neurobehavioral CRU (Kennedy Krieger) with functional
MRI facilities is also available to researchers
• Work with other ICTR units to coordinate areas such as
biostatistical consultation and training.
Translational Research Navigators
Leader: Daniel Ford
• Experienced research coordinators will be assigned to
research teams to help develop a plan for efficiently
moving protocols through regulatory offices
• Each research coordinator will have a person assigned
to work with them in each of the regulatory-based offices
at Johns Hopkins
• Will assist research teams in completing appropriate
applications and taking advantage of all science
opportunities
Biostatistical Support
Leader: Scott Zeger
• Johns Hopkins Biostatistics for Clinical and Translational
Research (Biostats CenTeR)
• Center coordinates biostatistics support to Johns
Hopkins translational research teams
• Provides practical advice on study design and
biostatistics questions
• Has library of previous biostatistics consultations for
review before consultation
• Encourages consultation at study design phase and
before data collection has been completed
Advanced Translation Incubator Program
- ATIP
Leader: Jeffrey Rothstein
• Research teams can apply for pilot grant funds to
support translational projects
• Investigators need to describe a “deliverable” product at
the end of funding
• Want to pilot a new focus on strict timelines with rapid
turnaround
• Can apply for up to $100,000 over two years
• New investigators, interdisciplinary teams, and research
teams with trainees are priorities
Clinical Research Management System CRMS
Leaders: Diana Gumas, Daniel Ford,
Stuart Ray, Kerry Stewart
• Application to register and follow research
participants
• Linked to eIRB and EPR
• Document eligibility and produce CRF
• Web-based secure system
Clinical Research Management System
EPR/Labs
Integration
External
Recruiting
Website
IRB Integration
Patient/
Protocol
Registry
Eligibility
Screening
Protocol
Schema /
Patient
Calendar
Budgeting
Sponsor
Billing
Billing
Compliance
Library
Research
Forms
Data
Warehouse
JHED/Site Minder Integration
Investigators
IRB
Key:
Research
Nurse
Program
Manager
Pharmacy
Core
Facilities
Currently
In Use
Work In
Progress
Data
Manager
Labs
Possible
Future
Functionality
Insurance
Clearance
SoM
Leadership
Budgeting by
Dept. Admin.
Billing
Compliance
Biomedical Informatics
Leaders: Harold Lehmann, Giovanni
Parmigiani
• Have programs responsible for knowledge
management, clinical research informatics,
biospecimen informatics, and bioinformatics
• Completing needs assessments in each area
• Prioritizing development of new biomedical
informatics applications
Research Participant Retention and
Recruitment Office
Leader: Cheryl Dennison
• Develop tools to monitor the success of various
recruitment and retention approaches used
within Johns Hopkins
• Provide consultations on various IRB-approved
recruitment strategies
• Develop Johns Hopkins strategic initiatives
focused on recruitment and retention
Johns Hopkins Data and Safety
Monitoring Board
Leaders: Fred Luthardt and Daniel Ford
• Help investigators who do not have access to a
DSMB develop a data and safety monitoring
plan
• If a DSMB is needed provide the structure and
administrative support for an institutional DSMB
• Communicate DSMB decisions to appropriate
IRBs
Research Ethics Achievement Program
Leader: Jeremy Sugarman
• Provides ethics consultations for research
groups concerning design and conduct of
studies
• Conducts empirical studies to inform policies
related to risks and benefits associated with
different study designs and consent procedures
Research Subject Advocate
Leaders: Liz Martinez and Daniel Ford
• Consultation to research teams about best ways
to work with research subjects
• Work with research teams who need an
intermediary for working with dissatisfied
research participants
Community Engagement Office
Leaders:
Charles Balch, Kostas Lyketsos, Chad Boult
and Peter Pronovost
• Community Research Network Office: Focus on
expanding sites and providers performing research, e.g. Anne
Arundel Medical Center; community physicians
• Community/Patient Research Partnership Office:
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Focus on working with patient disease advocacy groups to set
research agenda and enlist help with translational research projects
Secondary Translation Office: Focus on consultation
service for research teams as they design efficacy/effectiveness
studies. Consumers of research include patients, providers, payers,
and hospitals
Innovative Methodology Workgroups
Leader: Charles Flexner
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Identifies important and recurrent clinical
research methodologic and biostatistics
problems
Directs multidisciplinary work groups to
address these issues
Creates new methodologic approaches that
are available to the broad Johns Hopkins
community
Drug/Device/Vaccine Development
Leaders: Elizabeth Jaffee and Craig Hendrix
• Provides consultation to research teams on using
institutional resources to promote drug/device/vaccine
development
• Provides medicinal chemistry expertise for pre-clinical
toxicology
• Provides Good Manufacturing Practices (GMP) and
near-GMP for synthesis of biological reagents for
pre-clinical toxicology and early Phase 1 testing
• Provide pharmacologic and biologic endpoint expertise
• Individual and group seminars and hands on experience
with core technologies
Proteomics/Biomarker Core
Leader: Jennifer Van Eyk
• Integrates discovery and validation strategies
and technologies for the development of robust
biomarkers
• Assists in study design, cohort development,
appropriate experimentation and data analysis
as part of discovery process
• Develops and coordinates new technologies and
optimizes/standardizes protocols specifically for
biomarker development
• Individual and group seminars and hands on
experience with core technologies
Genetics Translational Technology Core
Leader: Gary Cutting
• Provide consultation to clinical and translational research
teams regarding the feasibility, design, power and costs
of projects using molecular technologies
• Provide clinical grade services such as DNA banking,
sequencing and genotyping for qualified investigators
• Can help evaluate test performance in a CLIA-certified
environment
• Individual and group seminars and hands on experience
with core technologies
Imaging Core
Leader: Katarzyna Macura
• Provides consultation for best imaging approach
in translational studies
• Developing an imaging library in cooperation
with Kennedy-Krieger Institute
Johns Hopkins ICTR Challenges
• Enhancing communication across the multiple programs
in the ICTR
• Finding best ways to leverage research infrastructure
– Relationships with various schools
– Relationships with cancer center
• Having the discipline to evaluate programs and
reallocate resources
• Creating an academic home for translational researchers
without a physical location
• Measuring output or translational research successes
• Identifying most productive approaches to working with
other academic institutions within CTSA
Communicating with the ICTR
• ICTR Main Line -- 443-287-ICTR (4287)
• ICTR Website – ictr.johnshopkins.edu
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News of program roll-outs, and upcoming events.
Additional Information about the ICTR.
Links to the national CTSA program
COMING SOON: A catalog of ICTR services, and a
catalog of resources at the JHMI that support clinical
and translational research.
– COMING SOON: For research subjects – a
searchable catalog of current clinical research taking
place in the School of Medicine.