Congressionally Directed Medical Research Programs CDMRP

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US Army Medical Research and Materiel Command
(USAMRMC)

• Congressionally Directed Medical Research
  Programs (CDMRP)
• Presented to
• National Institutes of Health
• Peer Review Advisory Committee
• Presented by
• Janet Harris, Ph.D., RNColonel, US Army Nurse
  Corps
• Director, CDMRP
• 27 August 2007

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CDMRP History

• 1992 Grassroots advocacy heightened political
  awareness of breast cancer
• 1993 Congress appropriated 210M to the
  Department of Defense budget for breast cancer
  research to be managed by the CDMRP after
  consultation with the Institute of Medicine (IOM)
  (re-reviewed the program in 1997)
• Additional research programs
• 1996 Neurofibromatosis
• 1997 Prostate Cancer and Ovarian Cancer
• 1999 Peer Reviewed Medical Research Program
• 2002 Prion, Tuberous Sclerosis Complex, and
  Chronic Myelogenous Leukemia
• 2006 Gulf War Veterans' Illnesses
• 2007 Autism Spectrum Disorder and Post-Traumatic
  Stress Disorder/Traumatic Brain Injury

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CDMRP Unique Features

• Funds added to the DOD budget by Congress
  generally as DHP(RDTE)
• Funds obligated for entire research project at
  time of award
• Respond to targeted guidance from Congress
• Two-tier review of proposals IOM Model
• Consumer advocate participation throughout
  process
• Vision adapted yearly to facilitate rapid change
  and address research gaps
• Highly flexible management processes

Defense Health Program (Research Development,
Test and Evaluation)
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CDMRP Funding History
Research Program
Millions ()
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CDMRP Program Process
Negotiations
USAMRMC Director Approval

• Portfolio balance
• Programmatic relevance
• Budget evaluation

Award Performance
Programmatic Review

• Science evaluation
• Budget evaluation

Peer Review
Proposal Receipt
Congressional Appropriation
Program Announcement Release
Vision Setting
Receipt of Funds
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CDMRP Program Process New Each Year, No
Resubmissions
Negotiations
USAMRMC Director Approval
Each year advocate groups go to Congress to
request funding for a specific program All
programs develop a new investment strategy each
year Resubmissions are not recognized - each
application must stand on its own merit

• Portfolio balance
• Programmatic relevance
• Budget evaluation

Award Performance
Programmatic Review

• Science evaluation
• Budget evaluation

Peer Review
Proposal Receipt
Congressional Appropriation
Program Announcement Release
Vision Setting
Receipt of Funds
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Innovation at the CDMRP

• Developing innovative electronic systems
• Soliciting innovative research ideas
• Utilizing innovative proposal review processes
• Pre-Application Submission
• Peer Review
• Programmatic Review

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Developing Innovative Electronic Systems

• CDMRP eReceipt System
• Web-based pre-application submission system
  (2001)
• Program and Peer Review Management Information
  System (P²RMIS)
• Proprietary web-based system owned and used by
  Constella Group (peer review contractor)
• Electronic Grants System (EGS)
• Custom-designed database and business system for
  paperless management of research proposals and
  grants (2001)
• Electronic Product Database
• Custom-designed database for management of
  research products (2006)
• Impact Increased efficiency, enhanced
  communication, and reduced applicant and program
  cost

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Soliciting Innovative Research Ideas

• Developing new award mechanisms to capture new
  ideas
• Impact, Multidisciplinary Postdoctoral
• Offering innovation-focused award mechanisms
• Innovator, Synergistic Idea, Era of Hope Scholar,
  Concept
• Providing clear definitions of innovation,
  impact, and synergy in Program Announcements
• Video for applicants emphasizing the critical
  elements in the Program Announcements under
  construction

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Utilizing Innovative Review Processes
Pre-application Submission

• Types of pre-applications
• Letter of Intent Default pre-application for
  most award mechanisms
• Nomination For awards that focus on Principal
  Investigator
• Preproposal For large and/or complex awards
• Requirement to submit pre-application allows
  program office to capture contact information on
  PI and AOR early in the process
• Submitted through eReceipt

Authorized Organizational Representative
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Utilizing Innovative Review Processes Peer
Review Panel Configuration

• Panel composition
• consumer advocates
• scientists from academia and industry
• clinicians from academia and private practice
• Stringent reviewer expertise standards
• Panel composition not made known to applicants
• No standing panels - Strive for 30 new
  reviewers
• No contact between applicants and panel members
• Review criteria definitions reviewed in
  pre-review video for peer reviewers

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Utilizing Innovative Review Processes Peer
Review Criteria

• Review criteria rank ordered to ensure focus on
  most important aspects of each unique award
  mechanism
• Synergistic Idea Award
• Innovation
• Synergy
• Impact
• Research Strategy
• Multidisciplinary Postdoctoral Award
• Principal Investigator
• Mentors
• Multidisciplinary Training and Environment
• Relevance and Impact
• Clinical Trial Award
• Trial Design
• Clinical Impact
• Intervention, Drug, or Device
• Feasibility

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Utilizing Innovative Review Processes Online
Electronic Peer Review

• Submission of initial review
• Scoring process
• Scored by assigned reviewers only
• Only adjectival scores used
• Virtual Panel discussion
• Asynchronous online
• Opportunity for reviewers to discuss differences
  of opinion
• Moderated by Chairperson
• Award mechanisms
• Concept
• Predoctoral Traineeship

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Utilizing Innovative Review Processes Peer
Review - Online Discussions (example)

• Conducted for proposals with disparate scores
• 269 proposals (22) had disparate scores that
  differed by two or more adjectival scores
• 243/269 (90) were discussed online
• 221/243 (91) received revised scores
• Disparately scored proposals were reduced from
  22 to 6

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Utilizing Innovative Review Processes In Person
Peer Review

• Blinded Review
• Science is focus
• Used for smaller awards
• Reviewers do not know PI or institution
• Expedited Review (Triage)
• Expedited review cut-point based on pre-meeting
  scores
• Developed algorithm based on peer review
  criteria, historical data
• Proposals with low enthusiasm not discussed
  unless championed
• Specialty Review
• Used for Innovator, EOH Scholar, EOH Postdoc
  Award mechanisms
• Reviewers are nontraditional (e.g., innovators,
  science journalists)
• Proposal are evaluated rather than scored
• Reviewers address innovation, leadership, and
  creativity

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Utilizing Innovative Review Processes Peer
Review Expedited Review
Proposal Receipt
Out
Modified Summary Statement
No
Expedited Review
Champion
Panel Assignment
Yes
In
Standard Summary Statement
Panel Discussion
Summary Paragraph
Final Scores/ Chair Summary
Initial Score Calculations
Panel Meeting
Post-Meeting
Pre-Meeting
Scientific Reviewer Consumer Reviewer
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Utilizing Innovative Review Processes Peer
Review Criteria - Specialty Reviews

• Innovator Award
• How the PIs record of accomplishment
  demonstrates outstanding ability as an
  independent and visionary scholar/investigator.
• Era of Hope Scholar Award
• What has the PI accomplished that demonstrates a
  history of innovation, productivity, and the
  potential for leadership in the breast cancer
  research community?
• Era of Hope Postdoctoral Award
• Whether the PI shows exceptional potential for
  an independent career at the forefront of breast
  cancer research.
• How the proposed training program and
  environment promotes the development of
  innovative breast cancer researchers.

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Utilizing Innovative Review Processes
Programmatic Review

• Score presentation
• Innovation-focused awards presented to
  Integration Panel in order of decreasing
  innovation score, not overall global score
• Resubmissions are not recognized - each
  application must stand on its own merit
• Blinded
• Science is focus
• Used for smaller awards
• Reviewers do not know who is conducting the
  proposed research or where it is being conducted
• Presentation of award mechanism successes
• Program Evaluation
• Product Database

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CDMRP Web Sitehttp//cdmrp.army.mil