part viii - villa-kaime presentation

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Department of Defense Congressionally Directed Medical Research Programs

US Army Medical Research and Materiel Command

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 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

CongressionalAppropriation

VisionSetting

ProgramAnnouncement

Release

ProposalReceipt

Peer Peer ReviewReview

Programmatic Review

USAMRMCDirectorApproval

Negotiations

Award Performance

Integration PanelReceipt

of Funds

� Science evaluation� Budget evaluation

� Portfolio balance� Programmatic relevance� Budget evaluation

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CDMRP Program Process New Each Year, No Resubmissions

CongressionalAppropriation

VisionSetting

ProgramAnnouncement

Release

ProposalReceipt

Peer Peer ReviewReview

Programmatic Review

USAMRMCDirectorApproval

Negotiations

Award Performance

Integration PanelReceipt

of Funds

� Science evaluation� Budget evaluation

� Portfolio balance� Programmatic relevance� Budget 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)

� 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

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

part viii - villa-kaime presentation

Documents

breast cancer research

additional research

address research gaps

entire research project

department of defense

materiel command funds

materiel commandcdmrp

dod budget