1 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research...

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Department of Defense Congressionally Directed Medical Research Programs

US Army Medical Research and Materiel Command

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Congressionally Directed Medical Research Programs (CDMRP)

Presented to National Institutes of Health

Peer Review Advisory Committee

Presented byJanet Harris, Ph.D., RN

Colonel, US Army Nurse CorpsDirector, CDMRP

27 August 2007

US Army Medical Research and Materiel Command (USAMRMC)

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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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Funds added to the DOD budget by Congress [generally as DHP(RDT&E)]*

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

CDMRP Unique Features

*Defense Health Program (Research Development, Test and Evaluation)

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CDMRP Funding HistoryCDMRP Funding History

0

100

200

300

400

500

600

700

FY92 FY95 FY97 FY99 FY01 FY03 FY05 FY07

PTSD/TBI

Gulf War Illness

Breast Cancer

Prostate Cancer

Neurofibromatosis

Ovarian Cancer

Peer Reviewed Medical

Amyotrophic Lateral Sclerosis

Autism

Chronic Myelogenous Leukemia

Tuberous Sclerosis

Myeloproliferative Disorders

Cooperative DOD/VA Medical

National Prion

Osteoporosis

Defense Women's Health

Institutionally Based Programs

Mill

ion

s ($

)

Research Program

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CDMRP Program Process

CDMRP Program Process

CongressionalAppropriationCongressionalAppropriation

VisionSettingVisionSetting

ProgramAnnouncement

Release

ProgramAnnouncement

Release

ProposalReceipt

ProposalReceipt

Peer Peer ReviewReview

Programmatic Review

Programmatic Review

USAMRMCDirectorApproval


Negotiations

Negotiations

Award Performance

Award Performance

Integration Panel

Integration PanelReceipt

of Funds

Receipt of

Funds

Science evaluationBudget evaluation

Portfolio balanceProgrammatic relevanceBudget evaluation

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CDMRP Program Process New Each Year, No Resubmissions

CDMRP Program Process New Each Year, No Resubmissions

CongressionalAppropriationCongressionalAppropriation

VisionSettingVisionSetting

ProgramAnnouncement

Release

ProgramAnnouncement

Release

ProposalReceipt

ProposalReceipt

Peer Peer ReviewReview

Programmatic Review

Programmatic Review



Negotiations

Negotiations

Award Performance

Award Performance

Integration Panel

Integration PanelReceipt

of Funds

Receipt of

Funds

Science evaluationBudget evaluation

Portfolio balanceProgrammatic relevanceBudget evaluation

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

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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)

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

Utilizing Innovative Review Processes Peer Review – Expedited Review

ProposalReceipt

PanelAssignment

Critiques/Scores

CR** SRSR*

Initial ScoreCalculations

Pre-Meeting

StandardSummaryStatement

ModifiedSummaryStatement

Expedited Review

Out

In

Champion

PanelDiscussion

Yes

No

SummaryParagraph

Panel Meeting

Final Scores/Chair Summary

Post-Meeting

*Scientific Reviewer**Consumer Reviewer

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Utilizing Innovative Review Processes Peer Review Criteria - Specialty Reviews

Innovator Award “How the PI’s 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

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