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Appendix A: Data Sources and Methods
Pages 147-158

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From page 147... ... 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. Read the entire page →
From page 148... ... 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. Read the entire page →
From page 149... ... 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 Read the entire page →
From page 150... ... Koroshetz, Deputy Director, NINDS, NIH Q&A with Panelists and Committee Discussion 4:45 Public Comment Period 5:00 Adjourn Read the entire page →
From page 151... ... 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 Read the entire page →
From page 152... ... 152 THE CTSA PROGRAM AT NIH 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 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 Read the entire page →
From page 153... ... 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 Read the entire page →
From page 154... ... 154 THE CTSA PROGRAM AT NIH 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 Read the entire page →
From page 155... ... APPENDIX A 155 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 Read the entire page →
From page 156... ... 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) Read the entire page →
From page 157... ... o accelerating the development of new therapeutics o facilitating disease-specific research o facilitating children's health and pediatric research o enhancing the integration of research funded by the NIH institutes and centers o involving and interacting with community organizations and patient advocacy groups?  Could the mission and strategic goals be improved to address these is sues? Read the entire page →

From page 147...

... 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.

Read the entire page →

From page 148...

... 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.

Read the entire page →

From page 149...

... 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

Read the entire page →

From page 150...

... Koroshetz, Deputy Director, NINDS, NIH Q&A with Panelists and Committee Discussion 4:45 Public Comment Period 5:00 Adjourn

Read the entire page →

From page 151...

... 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

Read the entire page →

From page 152...

... 152 THE CTSA PROGRAM AT NIH 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 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

Read the entire page →

From page 153...

... 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

Read the entire page →

From page 154...

... 154 THE CTSA PROGRAM AT NIH 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

Read the entire page →

From page 155...

... APPENDIX A 155 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

Read the entire page →

From page 156...

... 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)

Read the entire page →

From page 157...

... o accelerating the development of new therapeutics o facilitating disease-specific research o facilitating children's health and pediatric research o enhancing the integration of research funded by the NIH institutes and centers o involving and interacting with community organizations and patient advocacy groups?  Could the mission and strategic goals be improved to address these is sues?

Read the entire page →

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Appendix A: Data Sources and Methods Pages 147-158

Appendix A: Data Sources and Methods
Pages 147-158