Johns Hopkins Institute for Clinical and Translational Research A CTSA Program

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Johns Hopkins Institute forClinical 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

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Goals for the Meeting

• Introduce national and local CTSA program
• Suggest ways your department and CTSA can
  leverage resources
• Give us advice on how to transform clinical and
  translational research
• Identify department liaisons for the Institute
  for Clinical and Translational Research
• Will receive email this week asking for your
  department liaison designee

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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.

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Urgency to Change at Johns Hopkins

• 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

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Building a National CTSA Consortium
WA
ME
MT
ND
VT
MN
OR
NH
ID
WI
NY
MA
SD
WY
MI
RI
CT
NJ
IA
PA
NE
NV
OH
DE
IL
IN
UT
MD
CO
WV
VA
KS
MO
CA
KY
TN
AZ
OK
AR
SC
NM
GA
AL
MS
TX
LA
AK
FL
HI
Participating Institutions
Since 2006 Since 2007
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Building a National CTSA Consortium
FY06 Grantees Center for Clinical and
Translational ScienceThe Rockefeller University
Center for Clinical and Translational
SciencesUniversity of Texas Health Sciences
Center at Houston Clinical and Translational
Science CenterUniversity of California,
Davis Clinical and Translational Science
InstituteUniversity of Pittsburgh Clinical and
Translational Science Institute University of
California, San Francisco Clinical and
Translational Sciences InstituteUniversity of
Rochester School of Medicine and Dentistry Duke
Clinical and Translational Science InstituteDuke
University Institute for Translational Medicine
and TherapeuticsUniversity of Pennsylvania Irving
Institute for Clinical and Translational
Research Columbia University Mayo Center for
Translational Science ActivitiesMayo Clinic
Oregon Clinical and Translational Research
InstituteOregon Health and Science University
(partnering with Kaiser Permanente) Yale Center
for Clinical InvestigationYale University
FY07 Grantees Atlanta Clinical and Translational
Science Institute Emory University (partnering
with Morehouse College) CTSA at Case Western
UniversityCase 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
ResearchUniversity Of Wisconsin
Madison Institute for Clinical and Translational
Research Johns Hopkins Institute of
Translational Health Sciences University Of
Washington 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 CTSAUniversity 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)
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CTSAWeb.org
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Consortium Governance Organization
Governance Manual available at http//ctsaweb.org/
Docs/CTSA_Governance_Manual.pdf
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Translational Pathway
Diffusion to All Health Care Settings
Mechanistic Studies
Initial Human Testing
Basic Discovery
Proof of Efficacy
Proof of Effectiveness
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Institute for Clinical and Translational
ResearchInfluence on Scientific Discovery
Enhancing Formulation of Creation of
Development Conduct Analysis of
Publication Observation Scientific Question
Research Team Study Protocol of
Study Study Data Impact Study
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
Institute Programs
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Johns Hopkins Programs Before CTSA

• K12 Clinical Research Scholars Program
• Graduate Training in Clinical Investigation
• T32 Medical Student Training Program
• Johns Hopkins GCRC
• Inpatient
• Outpatient
• Pediatric
• Kennedy-Krieger Neurobehavioral Research Unit
• Bayview GCRC
• New Partners?

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Johns Hopkins Institute for Clinical and
Translational Research
NIH other government agencies
Research participant Recruitment office
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
Johns Hopkins ICTR
Industry
Participant Community Involvement
Clinical Resources
Biostatistics
Regulatory Support
Healthcare organizations
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Deputy Directors of the Institute for Clinical
and Translational Research

• Dr. Charles Balch
• Dr. Stephen Desiderio
• Dr. Elizabeth Jaffee
• Dr. Pamela Ouyang
• Dr. Neil Powe
• Dr. Christopher Saudek
• Dr. Pamela Zeitlin

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Johns Hopkins ICTRParticipating Schools

• School of Engineering
• School of Medicine
• School of Nursing
• School of Public Health

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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

• 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

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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

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Clinical Science Translational Forum

• Leaders Daniel Ford and Neil Powe
• 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

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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 biostatistical consultation, and 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

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Clinical Research Units
Leaders Pamela Ouyang (Bayview), Christopher
Saudek (JHH Broadway), Pamela Zeitlin
(Pediatrics), Michael Cataldo (Neurobehavioral
KKI)

• 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.

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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

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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

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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

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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

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Clinical Research Management System
EPR/Labs Integration
External Recruiting Website
IRB Integration
Protocol Schema / Patient Calendar
Budgeting Sponsor Billing
Patient/ Protocol Registry
Eligibility Screening
Billing Compliance
Data Warehouse
Tissue Banking
JHED/Site Minder Integration
Investigators
Research Nurse
Program Manager
Data Manager
Insurance Clearance
Budgeting by Dept. Admin.
SoM Leadership
Pharmacy
Core Facilities
Labs
Billing Compliance
IRB
Possible Future Functionality
Work In Progress
Currently In Use
Key
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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

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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

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Johns Hopkins Data and SafetyMonitoring 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

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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

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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

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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
  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

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Innovative Methodology Workgroups

• Leader Charles Flexner
• 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

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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

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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

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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

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Imaging Core

• Leader Katarzyna Macura
• Provides consultation for best imaging approach
  in translational studies
• Developing an imaging library in cooperation with
  Kennedy-Krieger Institute

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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

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Communicating with the ICTR

• ICTR Main Line -- 443-287-ICTR (4287)
• ICTR Website ictr.johnshopkins.edu
• 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.