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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (DC): National Academies Press (US); 2010.
Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary.
Show detailsThe goals of this workshop are to examine the state of clinical trials in the United States, identify areas of strength and weakness in our current clinical trial enterprise, and consider transformative strategies for enhancing the way clinical research is organized and conducted. Through a series of case studies and stakeholder perspectives, participants will examine clinical research networks in four disease areas—cardiovascular disease, depression, cancer, and diabetes. The goal is to understand the approaches that these networks have utilized in addressing the special issues and problems they face, successfully or not, and thereby derive lessons that can be applied throughout the clinical research enterprise.
Day One
Wednesday, October 7, 2009
8:30 a.m.–5:15 p.m.
| 8:30–8:35 | Welcome and Opening Remarks |
| Jeffrey Drazen, Workshop Chair | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| 8:35–10:00 | Session 1: State of the Clinical Research Enterprise |
This session will provide a broad overview of the current state of clinical research in the United States, its strengths and weaknesses, its recent evolution and future trajectory, and the types of problems that are commonly encountered in conducting clinical trials. In order to establish a baseline of data and an assessment of the current situation, a paper commissioned by the Institute of Medicine will be presented. A distinguished panel of experts will then discuss the paper’s conclusions and reflect on the state of clinical research from their own perspectives.
| Jeffrey Drazen, Moderator | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| 8:35–9:00 | Ronald Krall |
| GlaxoSmithKline (retired) | |
| 9:00–9:15 | Clifford Lane |
| National Institute of Allergy & Infectious Diseases, NIH | |
| 9:15–9:30 | Christopher Cannon |
| Harvard Medical School and Thrombolysis in Myocardial Infarction (TIMI) Study Group | |
| 9:30–9:45 | Paul Hébert |
| Canadian Medical Association Journal and Canadian | |
| Critical Care Trials Group | |
| 9:45–10:00 | Discussion/Q&A |
| 10:00–10:15 | Break |
Models of Clinical Research
Sessions 2 through 5 will examine approaches to organizing and conducting networks involved in large, multisite phase III clinical trials. In order to examine a cross section of contexts, the sessions will consider examples of research networks for the following types of conditions: acute/life threatening; chronic/not acutely life threatening; and chronic/life threatening. Speakers will draw upon their experiences in clinical research to distill lessons learned and make suggestions as to how we can improve the likelihood that a clinical trial will be successful (i.e., effective in translating trial results into actionable and useful information for clinical practice). Topics to be considered include
- Strategies for organizing clinical research networks—e.g., academic-industry relationships, centralized versus decentralized models, network size and scope, and established versus single-purpose networks;
- Differences between investigator-initiated, industry-driven, and patient group sponsored research efforts;
- Infrastructure to support researchers—e.g., information technology, training, enrollment, patient management systems, and overall funding per patient;
- Management of clinical research networks—e.g., standardization and quality control, incentives, use of performance metrics, informed consent issues, and payment issues; and
- Metrics for assessing the effectiveness of alternative approaches.
| Jeffrey Drazen, Workshop Chair | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| 10:15–11:30 | Session 2: Models of Clinical Research: Acute Myocardial Infarction & Heart Failure—Acute and Chronic Life-Threatening Conditions |
| Robert Califf, Moderator | |
| Duke University Medical Center | |
| 10:15–10:30 | Michael Lauer |
| National Heart, Lung, and Blood Institute, NIH | |
| 10:30–10:45 | Marc Sabatine |
| Harvard Medical School, Thrombolysis in Myocardial Infarction (TIMI) Study Group | |
| 10:45–11:00 | Robert Califf |
| Duke University Medical Center | |
| 11:00–11:30 | Discussion/Q&A |
| 11:30–12:45 | The Role of Clinical and Translational Science Awards (CTSA) in the Clinical Trial Process |
| 11:30–12:00 | Working lunch |
| 12:00–12:45 | Jeffrey Drazen, Moderator |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| Luncheon Keynote | |
| Barbara Alving | |
| National Center for Research Resources, NIH | |
| Discussion/Q&A | |
| 12:45–2:15 | Session 3: Models of Clinical Research: Depression— Chronic/Not Acutely Life-Threatening Condition |
| William Potter, Moderator | |
| Merck Research Labs | |
| 12:45–1:00 | Madhukar Trivedi |
| University of Texas Southwestern Medical Center | |
| 1:00–1:15 | William Potter |
| Merck Research Labs | |
| 1:15–1:30 | Amir Kalali |
| Quintiles, Inc. | |
| 1:30–1:45 | Jim McNulty |
| Depression and Bipolar Support Alliance | |
| 1:45–2:15 | Discussion/Q&A |
| 2:15–3:30 | Session 4: Models of Clinical Research: Cancer—Chronic/ Life-Threatening Condition |
| Renzo Canetta, Moderator | |
| Bristol-Myers Squibb | |
| 2:15–2:30 | Margaret Mooney |
| National Cancer Institute, NIH | |
| 2:30–2:45 | Renzo Canetta |
| Bristol-Myers Squibb | |
| 2:45–3:00 | Musa Mayer |
| AdvancedBC.org | |
| 3:00–3:30 | Discussion/Q&A |
| 3:30–3:45 | Break |
| 3:45–5:15 | Session 5: Models of Clinical Research: Diabetes—Chronic/ Not Acutely Life-Threatening Condition |
| Jay Skyler, Moderator | |
| University of Miami, Miller School of Medicine | |
| 3:45–4:00 | Judith Fradkin |
| National Institute of Diabetes and Digestive and Kidney Diseases, NIH | |
| 4:00–4:15 | Steven Kahn |
| VA Puget Sound Health Care System and University of Washington | |
| 4:15–4:30 | Jay Skyler |
| University of Miami, Miller School of Medicine | |
| 4:30–4:45 | Carla Greenbaum |
| Benaroya Research Institute | |
| 4:45–5:15 | Discussion/Q&A |
| Jeffrey Drazen, Workshop Chair | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| 5:15 | Adjourn |
Day Two
Thursday, October 8, 2009
8:00 a.m.–12:30 p.m.
| 8:00–9:15 | Envisioning a Transformed U.S. Clinical Research Enterprise |
| Jeffrey Drazen, Moderator | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| 8:00–8:30 | Janet Woodcock |
| Food and Drug Administration | |
| 8:30–9:15 | Reaction & Discussion |
| Robert Califf | |
| Duke University Medical Center | |
| Mikhail Gishizky | |
| Strategic Opportunity Ventures | |
| Peter Honig1 | |
| Merck Research Labs | |
| Steven Kahn | |
| VA Puget Sound Health Care System and University of Washington | |
| 9:15–11:00 | Session 6: Breakout Sessions |
During breakout sessions, participants will synthesize evidence presented in earlier sessions, and consider a range of strategies for transforming clinical research, with a focus on Phase III clinical trials, in order to advance toward a learning health care system. Promising models from existing research networks and collaborations will be considered along with innovative approaches that are as yet untried. A representative from each session will prepare a summary of the session’s conclusions and recommendations, and present them in plenary session, where they will be discussed by all attendees. These findings, in turn, will inform the subsequent workshops that will probe specific strategies and their public policy implications in depth.
The breakout groups will develop a concise set of findings and report back to the full session on the following:
- Describe a concise vision of clinical research (within this disease area) that more fully supports the goal of a learning health care system.
- Identify the gap between current practices and the vision described in 1.
- Identify best practices (from any disease area), or untested but potentially powerful approaches to organizing clinical trials, that could address this gap.
- Identify the key impediments to implementing such approaches that must be addressed—e.g., infrastructure, public/private investment, workforce, legal and institutional constraints, academic culture and traditions.
| Charge to the Breakout Groups | |
| Jeffrey Drazen, Workshop Chair | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| Breakout A: Acute Myocardial Infarction & Heart Failure—Acute and Chronic Life-Threatening Conditions | |
| Keck Room 100 | |
| Chair: Robert Califf, Duke University Medical Center | |
| Breakout B: Depression—Chronic/Not Acutely Life-Threatening Condition | |
| Keck Room 206 | |
| Chair: William Potter, Merck Research Labs | |
| Facilitator: Linda Brady, National Institute of Mental Health, NIH | |
| Breakout C: Cancer—Chronic/Life-Threatening Condition | |
| Keck Room 109 | |
| Chair: Renzo Canetta, Bristol-Myers Squibb | |
| Facilitator: Musa Mayer, AdvancedBC.org | |
| Breakout D: Diabetes—Chronic/Not Acutely Life-Threatening Condition | |
| Keck Room 208 | |
| Chair: Carla Greenbaum, Benaroya Research Institute | |
| Facilitator: Scott Campbell,2 American Diabetes Association | |
| 11:00–12:15 | Session 7: Breakout Reports |
| Jeffrey Drazen, Moderator | |
| Drug Forum Co-Chair | |
| New England Journal of Medicine | |
| 11:00–11:15 | Breakout A Report and Discussion |
| Robert Califf, Duke University Medical Center | |
| 11:15–11:30 | Breakout B Report and Discussion |
| William Potter, Merck Research Labs | |
| 11:30–11:45 | Breakout C Report and Discussion |
| Renzo Canetta, Bristol-Myers Squibb | |
| 11:45–12:00 | Breakout D Report and Discussion |
| Carla Greenbaum, Benaroya Research Institute | |
| 12:00–12:15 | Discussion/Next Steps |
| 12:15–12:30 | Closing Remarks and Adjournment |
| Gail Cassell | |
| Drug Forum Co-Chair | |
| Eli Lilly and Company | |
Footnotes
- 1
Since the workshop, Dr. Honig joined AstraZeneca as Head of Global Regulatory Affairs.
- 2
Since the workshop, Dr. Campbell joined the Foundation for the National Institutes of Health (FNIH) as Executive Director and CEO.
- Agenda - Transforming Clinical Research in the United StatesAgenda - Transforming Clinical Research in the United States
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