1. 1 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Archived File © ©The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.archivedOER Public Archive Home Page ©

2. 2 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 by Janet Harris, Ph.D., RN Colonel, US Army Nurse Corps Director, CDMRP 27 August 2007 US Army Medical Research and Materiel Command (USAMRMC)

3. 3 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command CDMRP History t 1992 Grassroots advocacy heightened political awareness of breast cancer t 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) t Additional research programs: v 1996 Neurofibromatosis v 1997 Prostate Cancer and Ovarian Cancer v 1999 Peer Reviewed Medical Research Program v 2002 Prion, Tuberous Sclerosis Complex, and Chronic Myelogenous Leukemia v 2006 Gulf War Veterans' Illnesses v 2007 Autism Spectrum Disorder and Post-Traumatic Stress Disorder/Traumatic Brain Injury

4. 4 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command t Funds added to the DOD budget by Congress [generally as DHP(RDT&E)]* t Funds obligated for entire research project at time of award t Respond to targeted guidance from Congress t Two-tier review of proposals – IOM Model t Consumer advocate participation throughout process t Vision adapted yearly to facilitate rapid change and address research gaps t Highly flexible management processes CDMRP Unique Features *Defense Health Program (Research Development, Test and Evaluation)

5. 5 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command CDMRP Funding History Millions ($) Research Program

6. 6 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command CDMRP Program Process Congressional Appropriation Congressional Appropriation Vision Setting Vision Setting Program Announcement Release Program Announcement Release Proposal Receipt Proposal Receipt PeerReview Programmatic Review USAMRMC Director Approval USAMRMC Director Approval Negotiations Award Performance Integration Panel Receipt of Funds t Science evaluation t Budget evaluation t Portfolio balance t Programmatic relevance t Budget evaluation

7. 7 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command CDMRP Program Process New Each Year, No Resubmissions Congressional Appropriation Congressional Appropriation Vision Setting Vision Setting Program Announcement Release Program Announcement Release Proposal Receipt Proposal Receipt PeerReview Programmatic Review USAMRMC Director Approval USAMRMC Director Approval Negotiations Award Performance Integration Panel Receipt of Funds t Science evaluation t Budget evaluation t Portfolio balance t Programmatic relevance t 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

8. 8 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Innovation at the CDMRP t Developing innovative electronic systems t Soliciting innovative research ideas t Utilizing innovative proposal review processes  Pre-Application Submission  Peer Review  Programmatic Review

9. 9 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Developing Innovative Electronic Systems t CDMRP eReceipt System v Web-based pre-application submission system (2001) t Program and Peer Review Management Information System™ (P²RMIS™) v Proprietary web-based system owned and used by Constella Group (peer review contractor) t Electronic Grants System (EGS) v Custom-designed database and business system for paperless management of research proposals and grants (2001) t Electronic Product Database v Custom-designed database for management of research products (2006) Impact: Increased efficiency, enhanced communication, and reduced applicant and program cost

10. 10 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Soliciting Innovative Research Ideas t Developing new award mechanisms to capture new ideas  Impact, Multidisciplinary Postdoctoral t Offering innovation-focused award mechanisms  Innovator, Synergistic Idea, Era of Hope Scholar, Concept t Providing clear definitions of “innovation,” “impact,” and “synergy” in Program Announcements  Video for applicants emphasizing the critical elements in the Program Announcements under construction

11. 11 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Pre-application Submission t 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 t Requirement to submit pre-application allows program office to capture contact information on PI and AOR* early in the process t Submitted through eReceipt *Authorized Organizational Representative

12. 12 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Peer Review Panel Configuration t Panel composition:  consumer advocates  scientists from academia and industry  clinicians from academia and private practice t Stringent reviewer expertise standards t Panel composition not made known to applicants t No “standing panels” - Strive for 30% new reviewers t No contact between applicants and panel members t Review criteria definitions reviewed in pre-review video for peer reviewers

13. 13 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Peer Review Criteria t Review criteria rank ordered to ensure focus on most important aspects of each unique award mechanism t Synergistic Idea Award  Innovation  Synergy  Impact  Research Strategy t Multidisciplinary Postdoctoral Award  Principal Investigator  Mentors  Multidisciplinary Training and Environment  Relevance and Impact t Clinical Trial Award  Trial Design  Clinical Impact  Intervention, Drug, or Device  Feasibility

14. 14 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Online Electronic Peer Review t Submission of initial review t Scoring process  Scored by assigned reviewers only  Only adjectival scores used t Virtual Panel discussion  Asynchronous online  Opportunity for reviewers to discuss differences of opinion  Moderated by Chairperson t Award mechanisms  Concept  Predoctoral Traineeship

15. 15 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Peer Review - Online Discussions (example) t Conducted for proposals with disparate scores v 269 proposals (22%) had disparate scores that differed by two or more adjectival scores v 243/269 (90%) were discussed online v 221/243 (91%) received revised scores t Disparately scored proposals were reduced from 22% to 6%

16. 16 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes In Person Peer Review t Blinded Review  Science is focus  Used for smaller awards  Reviewers do not know PI or institution t 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 t 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

17. 17 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Peer Review – Expedited Review Proposal Receipt Panel Assignment Critiques/Scores CR**SRSR* Initial Score Calculations Pre-Meeting Standard Summary Statement Modified Summary Statement Expedited Review Out In Champion Panel Discussion Yes No Summary Paragraph Panel Meeting Final Scores/ Chair Summary Post-Meeting *Scientific Reviewer **Consumer Reviewer

18. 18 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Peer Review Criteria - Specialty Reviews t Innovator Award  “How the PI’s record of accomplishment demonstrates outstanding ability as an independent and visionary scholar/investigator.” t 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?” t 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.”

19. 19 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command Utilizing Innovative Review Processes Programmatic Review t Score presentation  Innovation-focused awards presented to Integration Panel in order of decreasing innovation score, not overall global score t Resubmissions are not recognized - each application must stand on its own merit t Blinded  Science is focus  Used for smaller awards  Reviewers do not know who is conducting the proposed research or where it is being conducted t Presentation of award mechanism successes  Program Evaluation  Product Database

20. 20 Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command CDMRP Web Site http://cdmrp.army.mil