Clinical and Translational Research: Expectations and Goals

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Clinical and Translational ResearchExpectations
and Goals

• Daniel E. Ford, M.D., M.P.H.
• Director, Institute for Clinical and
  Translational Research
• Vice Dean for Clinical Investigation

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Clinical Research at Johns Hopkins

• Comprehensive in Scope
• Cancer Center
• Research in children
• Neurosciences
• Drug abuse
• Investigator Initiated
• Large Discovery Pipeline
• Expertise in Moving Discoveries to Population
• Fortunate to Have Large Number of Trainees
  Interested in Research

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Research at ClOffJohns Hopkins Medicine
By Calendar Year Last updated 4/5/2010      
New Applications   2007 2008 2009
  NHSR 35 48 99
  New Exempt 443 364 311
  New Expedited 561 688 830
  New Convened 418 520 569
         
  Total New 1457 1620 1809
         
Applications   2007 2008 2009
  Active eIRB Applications 1552 2198 2890
  Active Paper Applications 1051 859 554
  Active SOM IRB 2603 3057 3444
         
  WIRB Active Applications 405 297 200
  CIRB Active Applications 32 58 63
  Total Active 3040 3412 3707
         
Randomized Clinical Trials   2007 2008 2009
  Active Randomized Clinical Trials 724 815 854
  New Randomized Clinical Trials 247 376 405
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Commercial Applications   2007 2008 2009
  Active Commercial 550 543 487
  New Commercial 262 322 270
Commercial Clinical Trials   2007 2008 2009
  Active Commercial Clinical Trials 385 385 360
  New Commercial Clinical Trials 181 202 243
Using Drugs/Devices   2007 2008 2009
  Active Applications Using Drugs 869 1024 1091
  New Applications Using Drugs 282 346 386
         
  Active Applications using Devices 288 327 245
  New Applications using Devices 104 118 102
IDE/INDs Applications   2007 2008 2009
Investigator/Sponsor Held Active Applications using INDs 383 496 523
  New Applications using INDs 157 198 156
  Active INV Held INDs 74 118 162
  New INV Held INDs 13 55 82
         
  Active Applications using IDEs 12 29 44
  New Applications using IDEs 9 21 20
  Active INV Held IDEs 7 13 14
  New INV Held IDEs 3 3 2
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Sponsored Project SourcesJohns Hopkins SOM
Prorated Awards
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Translational Medicine

• T1 the transfer of new understandings of
  disease mechanisms gained in the laboratory into
  the development of new methods for diagnosis,
  therapy, and prevention and their first testing
  in humans.
• T2 the translation of results from clinical
  studies into everyday clinical practice and
  health decision making.
• IOM Clinical Research Roundtable

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Translational Research Activities

• T1 activities included 1) the translation of
  basic discovery into mechanistic studies in cell
  lines or animals, 2) the translation of
  mechanistic studies into initial human testing,
  and 3) the translation of initial human testing
  into proof of efficacy.
• The T2 activities included 1) the translation of
  proof of efficacy into proof of effectiveness in
  a usual care setting, and 2) research aimed at
  enhancing the adoption of best practices in the
  community

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Conclusions

• 69 responded they are translational researchers
  (9 other survey but different definition)
• PhD and fellows report less translational
  activity
• Barriers to translational research are as
  expected but substantial

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Barriers to Translational Research
(n205)


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Translational Pathway
Diffusion to All Health Care Settings
Basic Discovery
Mechanistic Studies
Initial Human Testing
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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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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Johns Hopkins and Translational Medicine

• Need to support researchers at all career levels
• Progress in translational medicine requires
  development of teams of researchers that
  appreciate all phases
• Clinical and translational researchers will
  continue to develop more technical and
  specialized approaches. Handoffs require active
  coordination (project coordinators).
• Do to increasing regulations, researchers will
  need to rely more on systematized solutions at
  institutional or national level
• Academic organizations need to partner better
  with other organizations to increase efficiency
  (industry, payers, patient groups)
• Need to balance resources/support for early and
  late translation
• Academic centers need better management structure
  to systematically monitor research process and
  barriers

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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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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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Institute for Clinical and Translational Research

• Goals
• Academic Home for Clinical and Translational
  Researchers
• Expand the Working Relationships of Clinical
  Investigators with Basic Scientists and
  Population-oriented Scientists
• Coordinate Translational Research Activities to
  Increase Innovation and Speed of Translation

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Institute for Clinical and Translational Research

• Goals
• Support Training of Clinical and Translational
  Research Faculty and Staff
• Provide Centralized Support for Research Where
  Efficient
• Measure and Track Efficiency of Human Subjects
  Research to Address Barriers
• Director Daniel Ford, MD, MPH Vice Dean for
  Clinical Investigation

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Deputy Directors of the Institute for Clinical
and Translational Research

• Dr. Charles Balch
• Dr. Stephen Desiderio
• Dr. Charles Flexner
• Dr. Elizabeth Jaffee
• Dr. Pete Miller
• Dr. Pamela Ouyang
• Dr. Jeff Rothstein
• Dr. Pamela Zeitlin

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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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Johns Hopkins ICTR Progams

• Translational research training
• K junior faculty/fellows
• Medical students
• Research staff and community physicians
• Clinical Research Units
• 1200 inpatient research bed days
• Over 10,000 outpatient research visits
• Pediatric and adult beds including Bayview

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Johns Hopkins ICTR Progams

• Biostatistical Consultation
• Innovative Methodology Workgroups
• Clinical Research Ethics Consultations
• Data and Safety Monitoring Services
• Translational Research Navigators (project
  managers)
• Clinical Research Management Database

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Johns Hopkins ICTR Progams

• Basic Discovery Translational Forum
• Clinical Sciences Translational Forum
• Accelerated Translational Incubator Program
  (ATIP) support pilots
• Research Participant Recruitment and Retention
  Program
• Community Research Networks Office
• Secondary Translation or Knowledge Transfer
  Office

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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
Library Research Forms
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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Translational Cores

• Genetics Core
• Proteomics/Biomarker Core
• Drug and Vaccine Development Core