PUBLIC ENGAGEMENT AND CLINICAL TRIALS: NEW MODELS AND DISRUPTIVE TECHNOLOGIES
June 27-28, 2011
Conduits and Department of Health Evidence and Policy
Mount Sinai School of Medicine
Goldwurm Auditorium
Icahn Medical Institute, 1st Floor
1425 Madison Ave. (at the NE corner of East 98th St.)
New York, NY 10029
Background:
Rapid advances in biomedical research have drawn attention to the critical need for an effective clinical trial system that can generate the evidence needed to translate discoveries into improved patient care, and illuminate targets for further innovation. There is growing recognition, however, that the U.S. clinical trial enterprise is unable to keep pace with the national demand for actionable research results, and inefficiencies in the clinical trial enterprise limit our ability to realize the clinical benefits of scientific discovery. Many clinical trials never meet their recruitment goals and others are accruing patients far too slowly. In addition, the divide between clinical research and clinical practice is growing wider—physicians working in real world clinical care settings are removed from the clinical trials on which medical evidence and care choices are ideally made. Successfully engaging
the broader public (including patients and communities) and medical professionals (community physicians and those practicing in academic medical centers) in the clinical trial enterprise is a significant challenge.
In light of these current challenges to clinical trials in the United States, this collaboration between the IOM Forum on Drug Discovery, Development, and Translation and Mount Sinai School of Medicine seeks to engage stakeholders and experts in an open discussion of current challenges and potential solutions to improving the capacity for efficient conduct of clinical trials in the United States through enhancing public engagement.
Meeting Objectives:
• Define and discuss the problem of inadequate public engagement in clinical trials.
• Identify the structures and culture of health care systems and delivery organizations that fail to support or engage with the clinical trial enterprise and suggest potential solutions for how health centers can be engaged to support the clinical trial enterprise.
• Discuss how academic medical centers can create successful community partnerships to improve public engagement in clinical trials.
• Highlight and discuss models/methods, both proven and yet to be tried, of public engagement. Address the media’s role in public engagement.
• Describe novel clinical trial designs (such as adaptive clinical trial designs) that minimize enrollment needs and address treatment assignment concerns of physicians and their patients.
• Involve stakeholders in a discussion of moving forward to create a comprehensive strategy for enhanced public engagement in clinical trials.
JUNE 27
SESSION I: FRAMING THE PROBLEM
Moderator: Jeffrey Drazen, Co-Chair, Forum on Drug Discovery, Development and Translation, New England Journal of Medicine
Session Objectives:
• Provide a definition of “engagement,” both public and professional, in clinical trials.
• Survey the current landscape in terms of deficiencies in public and professional engagement, and discuss consequences of this lack of engagement.
• Identify gaps/areas of particular need, desired outcomes of enhanced engagement, and the challenges facing this progress.
12:00-12:10 PM |
Welcome DENNIS CHARNEY, Dean, Mount Sinai School of Medicine JEFFREY DRAZEN, Co-Chair, Forum on Drug Discovery, Development and Translation, New England Journal of Medicine |
12:10-12:25 PM |
Shaping an Effective and Efficient Clinical Trial Enterprise: What Are the Challenges? ANNETINE GELIJNS AND DEBORAH ASCHEIM, Mount Sinai School of Medicine |
12:25-12:45 PM |
An Effective Clinical Trial System: A Perspective from the NIH Clinical Center JUAN LERTORA, National Institutes of Health |
12:45-1:30 PM |
Panel Discussion: A Perspective from Industry, Patient Advocates, Payors, and Regulatory Agencies LESLIE BALL, FDA JOAN FINNEGAN BROOKS, Patient-Focused Market Research ANGELA GEIGER, Alzheimer’s Association RICHARD MURRAY, Merck GREG SIMON, Pfizer BRUCE VLADECK, Nexera |
SESSION II: MODELS AND METHODS FOR PUBLIC ENGAGEMENT
Moderator: Nancy Sung, Burroughs Wellcome Fund
Session Objectives:
• Through case examples, discuss various stakeholder perspectives and efforts focused on public engagement. In case studies, identify
primary audiences, key messages, and success or lack of success in engaging the public.
• Present strategies that foster research interest and participation in diverse populations through innovative community partnerships.
1:35-1:50 PM |
Recruitment Challenges in Cardiothoracic Surgical Trials ROBERT MICHLER, Montefiore-Einstein Heart Center |
1:50-2:05 PM |
Diabetes, Clinical Trials, and Innovative Community Partnerships CAROL HOROWITZ AND NINA BICKELL, Mount Sinai School of Medicine |
2:05-2:20 PM |
Clinical Trials in Mental Health WAYNE GOODMAN, Mount Sinai School of Medicine |
2:20-2:35 PM |
Recruitment in Breast Cancer Trials, A New Approach: The Love/Avon Army of Women MARC HURLBERT, Avon Foundation Breast Cancer Crusade |
2:35-2:55 PM |
Panel Discussion KENNETH DAVIS, The Mount Sinai Medical Center ROBERT MICHLER, CAROL HOROWITZ, NINA BICKELL, WAYNE GOODMAN, MARC HURLBERT |
2:55-3:20 PM |
COFFEE BREAK |
SESSION III: TECHNOLOGIES AND NOVEL COMMUNICATION APPROACHES
Moderator: Janet Tobias, Mount Sinai School of Medicine
Session Objectives:
• Present innovative technologies/platforms that hold promise for achieving higher levels of public awareness (e.g., clinical trial matching; increasing adherence; online information efforts).
3:25-3:40 PM |
23andMe BRIAN NAUGHTON, Chief Scientist, 23andMe |
3:40-3:55 PM |
Social Networks and Public Engagement in Clinical Trials BERNADETTE BODEN-ALBALA, Columbia University |
3:55-4:15 PM |
Panel Discussion |
SESSION IV: MEDIA AND PUBLIC ENGAGEMENT IN CLINICAL TRIALS
Moderator: Paul Costello, Stanford School of Medicine
Session Objectives:
• Discuss the role in public engagement of media, health care information portals, and public advocates.
4:20-4:35 PM |
Survey of the Public Perception and Media Landscape CHRISTINA ZARCADOOLAS, CUNY and Mount Sinai School of Medicine JANET TOBIAS, Mount Sinai School of Medicine |
4:35-4:55 PM |
A Recent Trial of Pediatric Fluid Resuscitation and Novel Methods for Physician Engagement KATHRYN MAITLAND, Imperial College |
4:55-5:40 PM |
Panel Discussion: Public Information and Public Advocacy JOAN FINNEGAN BROOKS, Patient-Focused Market Research PEGGY PECK, MedPage Today ROGER SERGEL, ABC HEATHER WON TESORIERO, CBS CHRISTINA ZARCADOOLAS, CUNY and Mount Sinai School of Medicine |
JUNE 28
SESSION V: NOVEL CLINICAL TRIAL DESIGN
Moderator: Michael Krams, Johnson & Johnson
Session Objectives:
• Present novel clinical trial designs currently in use (e.g., adaptive trial designs), their strengths and weaknesses, and the desirability and/or feasibility of scaling up the widespread use of such designs.
• Discuss the ways in which novel clinical trial designs can enhance public engagement in clinical research and address treatment assignment concerns of physicians and their patients.
8:05-8:20 AM |
The Promise of Novel Trial Designs MICHAEL PARIDES, Mount Sinai School of Medicine |
8:20-8:35 AM |
Trial Designs Addressing Treatment Assignment Concerns LOUIS FIORE, VA Boston Healthcare System |
8:35-8:55 AM |
Perspective of the Food and Drug Administration (FDA) BRAM ZUCKERMAN, Center for Devices and Radiological Health, FDA |
DOUGLAS C. THROCKMORTON, Center for Drug Evaluation and Research, FDA |
|
8:55-9:15 AM |
Panel Discussion |
SESSION VI: HEALTH SYSTEM STRUCTURES AND CULTURE
Moderator: Harry Greenberg, Stanford University
Session Objectives:
• Present case studies that include a health system perspective on public and professional engagement methods and approaches and address broader culture and infrastructure/systemic issues.
• How can health systems develop a culture conducive to conducting clinical trials, including incentives for the careers of health professionals, systems approaches to better identify potential enrollees, engagement of referring physician community?
• For a health care delivery system, what are the suggested messages/approaches to enhance public support, understanding, buy-in, and ultimately participation in clinical trials? What organizations at the local level can be leveraged to achieve this?
• How can academic medical centers create effective community partnerships to improve public engagement in clinical trials?
9:20-9:35 AM |
Building a Clinical Trials Culture in Academia ERIC ROSE, Mount Sinai School of Medicine |
9:35-9:50 AM |
Exploring Novel Institutional Models in Cancer GEORGE DEMETRI, Dana-Farber Cancer Institute and Harvard Medical School |
9:50-10:05 AM |
New Organizational Models in Rheumatoid Arthritis Trials JAMES O’DELL, Rheumatoid Arthritis Investigational Network (RAIN), University of Nebraska |
10:05-10:20 AM |
ResearchMatch.org and Other IT Solutions PAUL HARRIS, Vanderbilt University |
10:20-10:40 AM |
Panel Discussion |
10:40-11:00 AM |
COFFEE BREAK |
11:00-11:45 AM |
Building Connections Between Community Physicians and Academic Medicine: The Challenges Panel Moderated by: HUGH SAMPSON, Mount Sinai School of Medicine SANFORD FRIEDMAN, The Mount Sinai Hospital RAFAT ABONOUR, Indiana University Simon Cancer Center RAMON MURPHY, Mount Sinai School of Medicine CAROL HOROWITZ, Mount Sinai School of Medicine |
SESSION VII: BUILDING A COMPREHENSIVE STRATEGY
Session Objectives:
• What are the most promising methods and messages for public and professional engagement that you heard during this meeting? What is the likelihood of action? How can they be prioritized?
• What would be the ideal technology to enhance public and professional engagement?
• What are the most pressing structural and cultural needs for a local health care system to enhance promotion of public and professional engagement and participation in clinical trials?
• What efforts aimed at physicians, researchers, patients, and the broader public will facilitate closing the gap between clinical researchers and clinical practitioners?
11:45 AM-12:05 PM |
The Changing Politics of Clinical Trial Engagement LARRY BROWN, Columbia University |
12:05-12:15 PM |
Building a Comprehensive Strategy: A Summary of the Meeting JEFFREY DRAZEN, New England Journal of Medicine |
12:15-12:30 PM |
Summary Discussion JEFFREY DRAZEN, New England Journal of Medicine JUAN LERTORA, National Institutes of Health GREG SIMON, Pfizer NANCY SUNG, Burroughs Wellcome Fund |
12:30 PM |
Adjourn |