National Academies Press: OpenBook
« Previous: References
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Appendix A

Workshop Agenda

Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020

November 7-8, 2011

20 F Street NW Conference Center 20 F Street NW Washington, DC 20001

Background:

There is increasing recognition that the clinical trials enterprise in the United States faces substantial challenges impeding the efficient and effective conduct of clinical and translational research needed to support the development of breakthrough medicines. A gap exists between the desired state where medical care in the United States is provided solely based on high-quality evidence and the reality of our limited ability to generate timely and practicable evidence. Eighty-five percent of clinical decisions in the United States are not supported by high-quality evidence. At the same time, U.S. clinical trials that generate medical evidence are becoming increasingly costly while experiencing greater setbacks. In addition, the shifting “footprint” of clinical trials toward sites outside the United States prompts questions about the generalizability and applicability of the results of those clinical trials to the U.S. population and represents a competitive challenge for the United States.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

The limited ability of the nation’s clinical trials system to support drug development and evaluation exists within a broader context of a need for a “learning health system,” where “knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the health care delivery process and leads to continual improvement in care.” An essential component of such a learning health system is a robust and well-working clinical trials enterprise to support drug development; inform quality improvement; and support surveillance, international, and comparative effectiveness research.

The IOM’s Forum on Drug Discovery, Development, and Translation has established an initiative to address challenges facing the U.S. clinical trials enterprise and to engage stakeholders in an open discussion of potentially transformative strategies to improve the efficiency and effectiveness of clinical trials.

Workshop Objectives:

•      Frame the problem and discuss a vision for a clinical trials enterprise that is efficient and effective and fully integrated into the health delivery system of 2020. Define how the envisioned clinical trials enterprise differs from the current system and suggest approaches to transform our current system into a learning system.

•      Consider the following core themes in framing an agenda to effect transformation of the U.S. clinical trials enterprise:

—  Providing a vision for a clinical trials enterprise in the health care system of 2020.

—  Developing a robust clinical trials workforce.

—  Aligning cultural and financial incentives.

—  Building an infrastructure to support a transformed clinical trials enterprise.

•      Workshop presentations and panel discussions will be supported

and supplemented by discussion papers prepared by participants

in Forum activities. Each of the four workshop sessions will be

prefaced by presentations from discussion paper authors.

NOVEMBER 7, 2011

8:30 a.m.           Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available

9:00 a.m.           Welcome and Introductions

JEFFREY DRAZEN, Workshop Chair

Editor-in-Chief

New England Journal of Medicine

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

SESSION I:
FRAMING THE NEED FOR CHANGE:
ENVISIONING A CLINICAL TRIALS ENTERPRISE IN THE HEALTH CARE SYSTEM OF 2020

Session Objectives:

•      Set a framework within which to establish a vision for 2020 that addresses the reinvention of the clinical trials enterprise around partnership with the institutional health care delivery system of 2020.

•      Given the anticipated changes in the structure of the U.S. health care system, consider how an efficient, effective clinical trials enterprise can be integrated into the health care delivery system of 2020.

ALASTAIR J.J. WOOD, Session Chair

Partner & Managing Director

Symphony Capital

9:10 a.m.           Presentation of Discussion Paper: The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation

ROBERT CALIFF

Director, Duke Translational Medicine Institute

Professor of Medicine

Vice Chancellor for Clinical and Translational Research

Duke University Medical Center

GARY FILERMAN

President

Atlas Health Foundation

RICHARD MURRAY

Vice President, Global Center for Scientific Affairs

Office of the Chief Medical Officer

Merck & Co., Inc.

10:00 a.m.           Panel Discussion with Speakers: A Framework for the Clinical Trials Enterprise in the Health Care System of 2020
Objectives:

•      Suggest and discuss the key components of a transformed clinical trials enterprise incorporated into the integrated health delivery system of 2020.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

•      Discuss the research outputs needed from the clinical trials enterprise to drive improved patient care and feed into a learning health system.

•      Consider broad transformational changes including the changing shape/structure of the pharmaceutical industry and the increasing globalization in clinical trials and drug development.

ALASTAIR J.J. WOOD, Panel Moderator

Partner & Managing Director

Symphony Capital

NEIL WEISSMAN

President

MedStar Health Research Institute

IHOR RAK

Vice President, Clinical Neuroscience

AstraZeneca

10:45 a.m.           BREAK

11:00 a.m.           Keynote Address: The Learning Health System

RICHARD PLATT

Professor, Harvard Medical School

Co-Chair, Clinical Effectiveness Research Innovation

Collaboration

IOM Roundtable on Value and Science-Driven Health Care

11:30 a.m.           Discussion with Keynote Speaker, Panelists, and Workshop Participants:

•      How can the national clinical trials enterprise fit into the envisioned learning health system?

•      What infrastructure is needed to embed randomized con-trolled trials in a learning health system?

•      What are the key barriers impeding integration of clinical trials into a learning health system (e.g., financial, cultural, regulatory)?

•      Where are the opportunities to address these barriers and build the needed infrastructure? What stakeholders/organizations/sectors should take the lead and how can their efforts best be coordinated?

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

PETER YU, Moderator

Oncologist, Palo Alto Medical Foundation

Chair, Electronic Health Record Working Group

American Society of Clinical Oncology

BRYAN LUCE

Senior Vice President, Science Policy

United BioSource Corporation

12:15 p.m.           LUNCH

SESSION II:
DEVELOPING A ROBUST CLINICAL TRIALS WORKFORCE

Session Objectives:

•      Define a clinical trials “workforce” and identify workforce needs that will be necessary to support clinical trials.

•      Given the defined workforce, discuss the needs for career paths and career development opportunities.

SHERINE GABRIEL, Session Chair

William J. and Charles H. Mayo Professor of Medicine &

Epidemiology Mayo Medical School

Co-Principal Investigator and Director of Education,

Mayo Clinical Center for Translational Scientific

Activities (CTSA)

1:15 p.m.           Presentation of Discussion Paper: Developing a Robust Clinical Trials Workforce

ROBERT CALIFF

Director, Duke Translational Medicine Institute

Professor of Medicine

Vice Chancellor for Clinical and Translational Research

Duke University Medical Center

ELAINE GALLIN

Principal

QE Philanthropic Advisors

MICHAEL LAUER

Director, Division of Cardiovascular Sciences

National Heart, Lung, and Blood Institute

National Institutes of Health

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

2:15 p.m.           Panel Discussion with Speakers: Developing and Sustaining a Clinical Trials Workforce
Objectives:

•      List key skills, techniques, and areas of expertise needed by the workforce.

•      What are the benchmarks and metrics of success for an effective clinical trials workforce?

•      Propose and discuss the core competencies of a clinical trials workforce.

SHERINE GABRIEL, Panel Moderator

William J. and Charles H. Mayo Professor of Medicine &

Epidemiology Mayo Medical School

Co-Principal Investigator and Director of Education,

Mayo Clinical Center for Translational Scientific

Activities (CTSA)

BRIGGS W. MORRISON

Senior Vice President, Worldwide Medical Excellence

Pfizer Inc.

REBECCA JACKSON

Professor and Associate Dean for Clinical Research

Director and Principal Investigator,

OSU Center for Clinical and Translational Science

The Ohio State University

3:00 p.m.           BREAK

3:15 p.m.           Keynote Address: Sustaining Institutional Support and Patient Engagement in Clinical Trials: Models and Messages from the NIH Clinical Center

JOHN GALLIN

Director

National Institutes of Health Clinical Center

3:45 p.m.           Discussion with Keynote Speaker, Panelists, and Workshop Participants:

•      What are the needs for patient and broader public engagement in clinical trials?

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

•      Discuss broad as well as disease-specific efforts to partner with patients in the development and conduct of clinical trials. How might these partnerships help create a national culture of clinical research in the United States?

•      How can models and best practices from the NIH Clinical Center be adapted to the realities of other institutions and community systems to advance and promote the conduct of clinical trials in those systems?

JANET TOBIAS, Moderator

Co-founder and Partner, Ikana Health

Adjunct Assistant Professor,

Mount Sinai School of Medicine

ANNETINE GELIJNS

Professor of Health Policy

Co-Chair, Department of Health Evidence and Policy

Mount Sinai School of Medicine

HEATHER SNYDER

Senior Associate Director, Scientific Grants

Medical and Scientific Relations

Alzheimer’s Association

4:30 p.m.           ADJOURN

Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020

NOVEMBER 8, 2011

8:30 a.m.           Breakfast available

9:00 a.m.           Welcome and Introductions

JEFFREY DRAZEN, Workshop Chair

Editor-in-Chief

New England Journal of Medicine

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

SESSION III:
ALIGNING CULTURAL AND FINANCIAL INCENTIVES

Session Objective:

•      Consider institutional needs to support clinical trials including addressing cultural issues and aligning financial incentives to support and sustain an efficient clinical trials enterprise.

ARTHUR H. RUBENSTEIN, Session Chair

Professor, Department of Medicine,

Division of Endocrinology

Raymond and Ruth Perelman School of Medicine

University of Pennsylvania

9:10 a.m.           Presentation of Discussion Paper: Transforming the Economics of Clinical Trials

JUDITH KRAMER

Associate Professor of Medicine,

Duke University Medical Center

Executive Director,

Clinical Trials Transformation Initiative (CTTI)

KEVIN SCHULMAN

Professor of Medicine and Business Administration

Duke University School of Medicine and

The Fuqua School of Business

9:50 a.m.           Panel Discussion with Speakers: Aligning Cultural and Financial Incentives to Support Clinical Trials
Objectives:

•      Discuss incentives, reward structures, and business models impacting the conduct of clinical trials, and the key needs and challenges for advancing and improving upon these models.

•      Consider regulatory, financial, and cultural changes that are needed to improve the environment for clinical trials.

ARTHUR H. RUBENSTEIN, Panel Moderator

Professor, Department of Medicine,

Division of Endocrinology

Raymond and Ruth Perelman School of Medicine

University of Pennsylvania

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

RICHARD RUDICK

Hazel Prior Hostetler Chair of Neurology,

Cleveland Clinic

Professor of Medicine,

Cleveland Clinic Lerner College of Medicine

Case Western Reserve University

CHRISTOPHER BEARDMORE

Chief Executive Officer

Translational Research Management

SCOTT STEELE

Director, Research Alliances

Adjunct Associate Professor,

Community and Preventive Medicine

University of Rochester

10:35 a.m.           BREAK

SESSION IV:
BUILDING AN INFRASTRUCTURE TO SUPPORT A TRANSFORMED CLINICAL TRIALS ENTERPRISE

Session Objectives:

•      Set out an organizational framework for an infrastructure to con-duct clinical trials.

•      Discuss:

—  organizational frameworks for the infrastructure (i.e., network models or other approaches);

—  informatics needs;

—  regulatory reform or harmonization both within the United States and internationally.

CLYDE YANCY, Session Chair

Magerstadt Professor of Medicine

Chief, Division of Cardiology

Feinberg School of Medicine

Northwestern University

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

10:55 a.m.           Presentation of Discussion Paper: Developing a Clinical Trials Infrastructure

PETRA KAUFMANN

Director, Office of Clinical Research

National Institute of Neurological Disorders and Stroke

National Institutes of Health

PAUL EISENBERG

Senior Vice President

Global Regulatory Affairs and Safety

Amgen Inc.

JANET WOODCOCK

Director, Center for Drug Evaluation and Research

U.S. Food and Drug Administration

11:45 a.m.           Panel Discussion with Speakers: Establishing an Infrastructure to Support a Transformed Clinical Trials Enterprise
Objectives:

•      Consider the types of trials that should be done in the United States and what the site/locus for the conduct of these trials should be within the infrastructure model proposed.

•      What are the roles and responsibilities of the various participants and stakeholders in the proposed infrastructure of the clinical trials enterprise?

CLYDE YANCY, Panel Moderator

Magerstadt Professor of Medicine

Chief, Division of Cardiology

Feinberg School of Medicine

Northwestern University

LOUIS FIORE

Principal Investigator, VA Cooperative Studies Program

Director, VA Cooperative Studies Program Coordinating

Center, Boston

Department of Veterans Affairs

MICHAEL KING JOLLY

Senior Vice President Quintiles Innovation

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

KAREN MARGOLIS

Professor of Medicine,

University of Minnesota Medical School

Director of Clinical Research

HealthPartners Research Foundation

12:30 p.m.           LUNCH

SESSION V:
DEVELOPING AN AGENDA FOR THE CREATION OF A TRANSFORMED CLINICAL TRIALS ENTERPRISE

Session Objectives:

•      Define the key steps and responsible parties needed to achieve the elements of a transformed clinical trials enterprise discussed during the workshop.

•      Consider the prioritization of transforming different elements of the clinical trials enterprise—what is feasible and most desirable?

•      Consider any unintended consequences of transforming the clinical trials enterprise.

•      Suggest a transformative path forward for decision makers and those implementing the work of clinical trials across the enterprise.

1:30 p.m.           JEFFREY DRAZEN, Session Chair
Editor-in-Chief
New England Journal of Medicine

Presentation of Key Themes/Suggested Paths from Session Chairs

ALASTAIR J.J. WOOD, Session I Chair Partner & Managing Director Symphony Capital

SHERINE GABRIEL, Session II Chair

William J. and Charles H. Mayo Professor of Medicine

& Epidemiology Mayo Medical School

Co-Principal Investigator and Director of Education,

Mayo Clinical Center for Translational Scientific

Activities (CTSA)

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

ARTHUR H. RUBENSTEIN, Session III Chair

Professor, Department of Medicine,

Division of Endocrinology

Raymond and Ruth Perelman School of Medicine

University of Pennsylvania

CLYDE YANCY, Session IV Chair

Magerstadt Professor of Medicine

Chief, Division of Cardiology

Feinberg School of Medicine

Northwestern University

2:30 p.m.           Reflecting on Potential Paths Forward: Setting an Agenda for a Transformed Clinical Trials Enterprise

JEAN ROULEAU

Scientific Director

Institute for Circulatory and Respiratory Health

Canadian Institutes of Health Research (CIHR)

JEFFREY DRAZEN, Panel Moderator

Editor-in-Chief

New England Journal of Medicine

DOUGLAS CROPPER

President and Chief Executive Officer

Genesis Health System

LYNN ETHEREDGE

Co-Founder

Health Insurance Reform Project and Rapid Learning Project

George Washington University

RONALD KRALL

Associate Fellow

University of Pennsylvania, Center for Bioethics

JAMES DOROSHOW

Director, Division of Cancer Treatment and Diagnosis

National Cancer Institute, National Institutes of Health

4:30 p.m.           ADJOURN

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 85
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 86
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 87
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 88
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 89
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 90
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 91
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 92
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 93
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 94
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 95
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 96
Next: Appendix B: Participant Biographies »
Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary Get This Book
×
Buy Paperback | $49.00 Buy Ebook | $39.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions.


With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!