EVALUATION OF THE

Congressionally Directed
Medical Research Programs

REVIEW PROCESS

Committee on the Evaluation of Research Management by DoD
Congressionally Directed Medical Research Programs (CDMRP)

Board on the Health of Select Populations

Health and Medicine Division

A Report of

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This study was supported by Contract/Grant No. HHSP233201400020B between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-45001-0
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Digital Object identifier: 10.17226/23652

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Evaluation of the Congressionally Directed Medical Research Programs Review Process. Washington, DC: The National Academies Press. doi: 10.17226/23652.

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COMMITTEE ON THE EVALUATION OF RESEARCH MANAGEMENT BY DOD CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS (CDMRP)

KENNETH W. KIZER (Chair), University of California, Davis

JAMES M. ANDERSON, Case Western Reserve University

MARJORIE A. BOWMAN, Wright State University

MARINA BROITMAN, Patient-Centered Outcomes Research Institute (PCORI)

CARL A. CASTRO, University of Southern California

KAY DICKERSIN, Johns Hopkins Bloomberg School of Public Health

MAHA HUSSAIN, Northwestern University

VICKIE MAYS, University of California, Los Angeles

RELFORD (CHIP) PATTERSON, Comprehensive Health Services, Incorporated

BARBARA J. TURNER, University of Texas Health Science Center at San Antonio

MYRL WEINBERG, National Health Council (Retired)

Study Staff

ROBERTA WEDGE, Study Director

ANNE STYKA, Program Officer

HEATHER L. CHIARELLO, Research Associate

NICOLE FREID, Senior Program Assistant

JULIE WILTSHIRE, Financial Officer

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Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of the independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following for their review of the report:

Lars F. Berglund, University of California, Davis

John Feussner, Medical University of South Carolina

Melissa Forsythe, Livingston, Texas

Uta Francke, Stanford University School of Medicine

Gary Gackstetter, Uniformed Services University of the Health Sciences

Barbara Hempstead, Weill Cornell Medical College

Melissa Kaime, Gene Upshaw Memorial Tahoe Forest Cancer Center

Story Landis, National Institute of Neurological Disorders and Stroke (Retired)

Wilbur K. Milhous, University of South Florida College of Public Health

Amy Comstock Rick, Food and Drug Law Institute

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by Martin A. Philbert, University of Michigan, and Philip J. Cook, Duke University. They were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Acknowledgments

This report was greatly enhanced by the participants at the open sessions held by the committee as well as by others who participated in informal data-gathering interviews with the study staff. Additionally, a great deal of information was provided by the Congressionally Directed Medical Research Programs (CDMRP) leadership and staff in response to committee questions throughout the course of the study.

The committee would like to acknowledge the efforts of those who gave presentations and who provided materials to the committee during the course of the study’s information-gathering period (in alphabetical order): Fred Atkin (Action to Cure Kidney Cancer), Linda Bambrick (CDMRP staff), Carolyn Best (American Urological Association), Timothy Brindle (Department of Veterans Affairs), Col. Carlton Brinkley (CDMRP staff), Kelley Brix (Department of Defense, Defense Health Agency), Ron Brown (National Gulf War Resource Center), Lucie Bruijn (ALS Association), Deborah Cory-Slechta (University of Rochester School of Medicine), Angel Davey (CDMRP staff), Colleen Gaydos (Senate Committee on Appropriations staff), Theresa Gleason (Department of Veterans Affairs), Amelie Gubitz (National Institute of Neurological Disorders and Stroke), Anthony Hardie (Veterans for Common Sense), Rogene Henderson (Lovelace Respiratory Research Institute), Lyn Jakeman (National Institute of Neurological Disorders and Stroke), Howard M. Kipen (Rutgers University School of Public Health), Audrey Kusiak (Department of Veterans Affairs), Robin Levy (Lymphoma Research Foundation), Bryan Lewis (Action to Cure Kidney Cancer), Kristy Lidie (CDMRP staff),

Carlos Maldonado (Department of Veterans Affairs), Beverly Michaels (CDMRP staff), Debora Moritz (tuberous sclerosis advocate), Jill Morris (National Institute of Neurological Disorders and Stroke), Denise Nichols (Gulf War illness advocate), Col. Wanda Salzer (Director, CDMRP), Ray Santullo (CDMRP staff), Gayle Vaday (CDMRP staff), Frances Visco (National Breast Cancer Coalition), and Rick Weidman (Vietnam Veterans of America).

The committee also greatly appreciates the contributions of the hundreds of former peer and programmatic reviewers who anonymously responded to the committee’s solicitation of input. The information that was provided by all of those mentioned above helped to set the stage for fruitful committee discussions.

Contents

ACRONYMS AND ABBREVIATIONS

SUMMARY

Committee’s Statement of Task and Approach

The CDMRP Review Process

Participants in the Process

Consumer Engagement

Findings and Recommendations

Conclusions

1 INTRODUCTION

Prior Reports on CDMRP

Charge to the Committee

Committee’s Approach to Its Charge

Organization of the Report

2 OVERVIEW OF THE CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

The Current CDMRP

CDMRP Funding

Overview of the CDMRP Review Process

3 PARTICIPANTS IN THE PROCESS

CDMRP Personnel

CDMRP Contractors

Review Panels

4 VISION SETTING AND THE PRE-APPLICATION PROCESS

Stakeholders Meetings

The Vision Setting Process

Pre-Application Receipt and Screening

5 PEER REVIEW

Pre-Meeting Activities

The Peer Review Meeting

Post-Meeting Activities and Deliverables

6 PROGRAMMATIC REVIEW

Pre-Meeting Activities

The Programmatic Review Meeting

Post-Meeting Activities and Deliverables

7 COORDINATION OF RESEARCH PRIORITIES

Medical Research Funding in the United States

Committee’s Approach to Coordination

Establishing Research Priorities

Avoiding Research Duplication

8 FINDINGS AND RECOMMENDATIONS

Consumer Engagement

Strategic Planning

Coordination

Transparency

Standardization

Implementation of the 1993 and 1997 IOM Recommendations

Conclusions

REFERENCES

APPENDIXES

A Committee Biographical Sketches

B Open Session Agendas

Acronyms and Abbreviations