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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

A

Data Sources and Methods

The Institute of Medicine (IOM) Committee to Review the Clinical and Translational Science Awards (CTSA) Program at the National Center for Advancing Translational Sciences (NCATS) was tasked with providing an independent appraisal of the CTSA Program. The specific goals of this congressionally requested review were to assess the CTSA Program’s mission and goals and to explore the contributions of the CTSA Program in accelerating the development of new therapeutics, in facilitating disease-specific research and children’s health research, and in enhancing the integration of programs funded by the National Institutes of Health (NIH) institutes and centers. In conducting its work and responding to the statement of task, the IOM committee reviewed information that was collected from a variety of sources, including scientific literature, previous evaluations and progress reports, open-session meetings and conference calls, public testimony and input, and other publicly available resources.

COMMITTEE EXPERTISE

The study committee comprised 13 individuals with expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research, along the full continuum of clinical and translation research. Appendix B provides biographical sketches of each of the committee members. The committee’s expertise was supplemented by the

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

knowledge and insights of a number of experts who presented research during open-session meetings and conference calls.

OPEN-SESSION MEETINGS, CONFERENCE CALLS, AND PUBLIC INPUT

Between October 2012 and February 2013, the committee convened three open-session meetings and four open-session conference calls (Boxes A-1 to A-7). The committee’s first meeting in October was held remotely via conference call because of weather conditions associated with Hurricane Sandy. Over the course of the study, the committee also held a number of closed-session conference calls and a closed-session meeting in March 2013 to conclude its deliberations. The open-session meetings and calls allowed the committee to hear from a wide range of stakeholders, including a number of CTSA principal investigators and researchers, members of the NCATS and NIH leadership, community and patient advocacy organizations, industry partners and representatives, and thought leaders and researchers in the clinical and translational sciences arena who were not connected to the CTSA Program.

Each of the open-session meetings included a public comment period that allowed the committee to hear from other researchers, stakeholders, and members of the public. Because of budget constraints, all of the open-session meetings were held in Washington, DC. To provide additional opportunities for public input by individuals who were unable to travel to the meetings or participate by conference call, the committee used an online public input tool with questions to guide further testimony and input. A link to the public input tool was made available on the IOM’s website from December 2012 through March 2013. The NCATS and IOM study listservs were used to notify stakeholders and the public about the opportunity to provide additional input to the committee’s work and the availability of the online tool. The list of questions included in the public input tool can be found in Box A-8. During the 3 months that the tool was available, 27 individuals submitted responses to the questions. This input was catalogued in the study’s public access file and is available by request through the National Academies’ Public Access Records Office. The committee also reviewed input submitted through its e-mail address, CTSAReview@nas.edu, throughout the duration of the study.

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

INFORMATION GATHERING AND DOCUMENT REVIEW

In addition to information that was gathered during the open-session meetings and conference calls, the committee conducted a review of the available scientific literature with a focus on areas related to the CTSA Program and its work in clinical and translational sciences, training and education, community engagement, and child health research. The committee also reviewed previous evaluations of the CTSA Program, including the reports from the 3-year Westat evaluation and the evaluation of the administration of the CTSA Program under the NIH’s National Center for Research Resources that was conducted by the Department of Health and Human Services’ Office of the Inspector General; progress reports developed by the CTSA Consortium committees and the NIH; responses to the NIH’s requests for information related to the CTSA Program; a wealth of information provided by NCATS, a range of CTSA Consortium committees, and stakeholder groups; and results and recommendations from other working groups and stakeholder meetings that have considered the future directions of the CTSA Program. Any information that was provided to the committee from outside sources was catalogued in the study’s public access file and is available by request through the National Academies’ Public Access Records Office.

BOX A-1
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences 500 Fifth Street, NW Washington, DC

Monday, October 29, 2012

Agenda

9:30 – 9:45

Welcome and Introductions

Alan Leshner, Committee Chair

Sharon Terry, Committee Vice-Chair

9:45 – 11:30

Charge to the Committee and Discussion of Statement of Task

Chris Austin, Director, NCATS, NIH

Josie Briggs, Acting Director, Division of Clinical Innovation, NCATS, NIH

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
11:30 – 12:30 Lunch Break
12:30 – 2:30

Overview of CTSA Committees and Strategic Goals

CTSA Consortium Steering and Executive Committees

Bradley Evanoff, Washington University

Goal 1: National Clinical and Translational Research Capability

Clay Johnston, University of California, San Francisco

Goal 2: Training and Career Development of Clinical/Translational Scientists

Robert Toto, University of Texas Southwestern Medical Center

Goal 3: Consortium-Wide Collaborations

Anantha Shekhar, Indiana University

Goal 4: Health of Our Communities and the Nation

Kathleen Brady, Medical University of South Carolina

Goal 5: Advance T1 Translational Research

Nora Disis, University of Washington

Q&A with Panelists and Committee Discussion

2:30 – 2:45 Break
2:45 – 4:45

Enhancing Integration: CTSAs and NIH Institutes and Centers

2:45 – 4:45

National Cancer Institute

Linda Weiss, Director, Office of Cancer Centers, NCI, NIH

National Heart, Lung, and Blood Institute

Susan Shurin, Deputy Director, NHLBI, NIH

National Institute of Allergy and Infectious Diseases

Hugh Auchincloss, Deputy Director, NIAID, NIH

National Institute of Diabetes and Digestive and Kidney Diseases

Gregory G. Germino, Deputy Director, NIDDK, NIH

National Institute of Neurological Disorders and Stroke

Walter J. Koroshetz, Deputy Director, NINDS, NIH

Q&A with Panelists and Committee Discussion

4:45

Public Comment Period

5:00 Adjourn
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

BOX A-2
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

Conference Call – November 19, 2012 11 a.m. to Noon (Eastern)

Agenda

11:00 – 12:00 Open Session
Nora Volkow, NIDA
Steve Katz, NIAMS

BOX A-3
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

Conference Call – November 30, 2012 10:30 a.m. to Noon (Eastern)

Agenda

10:30 – 12:00 Open Session
Steve Hirschfield, NICHD
Dianne Murphy, FDA
Charles Thompson, Pfizer Inc.
Ron Portman, Bristol-Meyers Squibb
Phil Pizzo, Stanford University

BOX A-4
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

National Academy of Sciences Building 2101 Constitution Avenue, NW Washington, DC

Wednesday, December 12, 2012

Agenda

8:00 – 8:05

Welcome and Opening Remarks

Alan Leshner, Chair

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
8:05 – 8:20

CTSA Overview – Goals of the Program

Tom Insel, National Institute of Mental Health, NIH

8:20 – 9:50

Panel 1: Translation of Basic Science to Human Studies: Advancing T1 and T2 Research

Facilitator: Cliff Rosen

  8:20 – 8:25

Panel Introductions

  8:25 – 8:35

CTSA Perspective

Garret FitzGerald, University of Pennsylvania

  8:35 – 8:45

CTSA Perspective
Sundeep Khosla, Mayo Clinic

  8:45 – 8:55

Community Perspective

Bernard Ewigman, University of Chicago

  8:55 – 9:05

Industry Perspective

Jacqueline B. Fine, Merck Research Laboratories

  8:55 – 9:05

Industry Perspective

Jacqueline B. Fine, Merck Research Laboratories

  9:05 – 9:50

Discussion with the Committee

9:50 – 10:00 Break  
10:00 – 11:30

Panel 2: Children’s Health Research: Role of the CTSA Program

Facilitators: Meg McCabe and Phyllis Dennery

  10:00 – 10:05

Panel Introductions

  10:05 – 10:15

CTSA Consortium Child Health Oversight Committee

Jonathan Davis, Tufts University

  10:15 – 10:25

CTSA Perspective

Margaret Grey, Yale School of Nursing

  10:25 – 10:35

CTSA Perspective

Terence Flotte, University of Massachusetts

  10:35 – 10:45

Community Perspective

Susan Weiner, Children’s Cause for Cancer Advocacy

  10:45 – 11:30

Discussion with the Committee

11:45 – 12:30 Lunch
12:30 – 1:45

Panel 3: Collaborations Across CTSAs: Current Status and Future Plans

Facilitator: Sue Curry

  12:30 – 12:35

Panel Introductions

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
  12:35 – 12:45

CTSA Coordinating Center (C4) Overview

Gordon Bernard, Vanderbilt University

  12:45 – 12:55

Collaborations on Informatics

Paul Harris, Vanderbilt University

  12:55 – 1:05

CTSA Perspective

Marc Drezner, University of Wisconsin

  1:05 – 1:15

Community Perspective

Mickey Eder, Access Community

Health Network, Chicago

  1:15 – 1:45

Discussion with the Committee

1:45 – 3:00

Panel 4: Evaluating the CTSA Program


Facilitator: Robin Kelley

  1:45 – 1:50

Panel Introductions

  1:50 – 2:00

Westat Evaluations

Joy Frechtling, Westat

  2:00 – 2:10

NCATS Request for Information Josie Briggs, NCATS, NIH

  2:10 – 2:20

NCATS/CTSA Integration Working Group

Steve Katz, NIAMS, NIH

  2:20 – 2:30

Evaluating Large Scale Programs—Frameworks and Considerations David Chavis, Community Science

  2:30 – 3:00

Discussion with the Committee

3:00 – 3:15 Break
3:15 – 4:45

Panel 5: Roundtable Discussion: Future Directions for the Mission and Goals of the CTSA Program

  3:15 – 3:20

Roundtable Introductions

  3:20 – 4:00

Opening Comments on the CTSA Program

Tachi Yamada, Takeda

Pharmaceuticals (via conference call)

Wylie Burke, University of Washington (via conference call)

John Adams, University of California, Los Angeles

  4:00 – 4:45

Roundtable and Committee Discussion

4:45 – 5:30 Public Comment Period
5:30 Adjourn
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

BOX A-5
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

20F Conference Center 20 F Street, NW Washington, DC

Thursday, January 24, 2013

Agenda

8:00 – 8:05

Welcome and Opening Remarks

Alan Leshner, Chair

8:05 – 8:45

Opening Speaker

Chris Austin, NCATS

8:45 – 10:10

Panel 1: Training and Education

Facilitator: Cliff Rosen

  8:45 – 8:50

Panel Introductions

  8:50 – 9:30

Panel Presentations

David Shackelford, University of California Los Angeles

Lisa Ceglia, Tufts University

Kelly Edwards, University of Washington

Cynthia Morris, Oregon Health and Science University

  9:30 – 10:10

Discussion with the Committee

10:10 – 10:20 Break
10:20 – 11:45

Panel 2: Engaging Community Organizations and Patient Advocacy Groups

Facilitators: Sharon Terry and Susan Axelrod

  10:20 – 10:25

Panel Introductions

  10:25 – 11:05

Panel Presentations

Donna Appell, Hermansky-Pudlak Syndrome Network Inc.

Bray Patrick-Lake, Clinical Trials Transformation Initiative

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
   

Sarena Seifer, Community-Campus Partnerships for Health

Joan Reede, Harvard University

  11:05 – 11:45

Discussion with the Committee

11:45 – 12:30 Lunch Break
12:30 – 2:00

Panel 3 Advancing Research on Clinical Practice and Population Health: T3 and T4 Research

Facilitator: Ann Bonham

  12:30 – 12:35

Panel Introductions

  12:35 – 1:15

Panel Presentations

Lloyd Michener, Duke University

Joe Selby, PCORI (Patient-Centered Outcomes Research Institute) Leonard Sacks, FDA

John Steiner, Kaiser Permanente Colorado

  1:15 – 2:00

Discussion with the Committee

2:00 – 3:15

Panel 4: Future Directions for Using CTSA Programs and Resources

Facilitator: Ralph Horwitz

  2:00 – 2:05

Panel Introductions

  2:05 – 2:35

Panel Presentations

Robert Califf, Duke University

Martha Curley, University of Pennsylvania Edith Parker, University of Iowa

  2:35 – 3:15

Discussion with the Committee

3:15 – 3:30 Break
3:30 – 5:00

Panel 5: Roundtable Discussion: Future Directions for the Mission and Goals of the CTSA Program

Facilitator: Edith Perez

  3:30 – 3:35

Roundtable Introductions

  3:35 – 4:05

Opening Comments on the CTSA Program

Morrie Schambelan, University of California, San Francisco

Stephen Thomas, University of Maryland Gigi Hirsch, Massachusetts Institute of Technology

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
  4:05 – 5:00

Roundtable and Committee Discussion

5:00 – 5:30

Public Comment Period

5:30

Adjourn

BOX A-6
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

Conference Call – January 30, 2013 12:30 to 2:00 p.m. (Eastern)

Agenda

12:30 – 2:00

Open Session

  12:35 – 12:40

Welcoming Remarks

Alan Leshner, Committee Chair

  12:40 – 12:50

Petra Kaufmann, NINDS, NIH

  12:50 – 1:00

Committee Q&A

  1:00 – 1:20

Discussion with Francis Collins, NIH

  1:20 – 1:30

Eric Topol, Scripps Research Institute

  1:30 – 2:00

Committee Q&A

BOX A-7
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

Conference Call – February 27, 2013 3:30 to 4:30 p.m. (Eastern)

Agenda

3:30 – 4:30

Open Session

Discussion with Chris Austin, Director of NCATS

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

BOX A-8
Public Input Questions

Mission

• Is the mission of the CTSA Program clear and appropriate for defining the success of the program and for supporting the mission of NCATS?

• Is the scope of the mission realistic given the available resources, support, and infrastructure?

• Is the mission being disseminated adequately? Are potential stakeholders aware of the resources available through the CTSA Program, and are there barriers to the use of those resources?

Strategic Goals

• Are the strategic goals of the CTSA Program clear and appropriate? Do they clarify the purpose and mission of the CTSA Program?

• Are the strategic goals realistic given the available resources, support, and infrastructure?

• Are the strategic goals being disseminated adequately?

• Do you have suggestions for refocusing and revising the strategic goals of the CTSA Program?

Role of the CTSA

• Since the inception of the CTSA Program, have the CTSA institutions, individually and collectively, played an appropriate and adequate role in: (please check the boxes where you believe the CTSA Program has played an adequate and appropriate role)

accelerating the development of new therapeutics

facilitating disease-specific research

facilitating children’s health and pediatric research

enhancing the integration of research funded by the NIH institutes and centers

involving and interacting with community organizations and patient advocacy groups?

• Could the mission and strategic goals be improved to address these issues? If so, how should they be improved?

Continuum of Research

• Please comment on the balance of CTSA Program efforts across the continuum of research from first-phase studies in humans to clinical trials to population-based research on health outcomes and comparative effectiveness.

• Does the balance need to shift? Why or why not?

Successes, Challenges, and Future Directions

• What do you see as successes, challenges, and future directions of the CTSA Program?

Additional Comments

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×

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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, DC: The National Academies Press. doi: 10.17226/18323.
×
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In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country.

The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research.

The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.

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