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Appendix A
Workshop Agenda
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
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90 PUBLIC ENGAGEMENT AND CLINICAL TRIALS
the broader public (including patients and communities) and medical pro-
fessionals (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, Develop-
ment, 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:
• efine and discuss the problem of inadequate public engagement in
D
clinical trials.
• dentify the structures and culture of health care systems and deliv-
I
ery 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.
• iscuss how academic medical centers can create successful commu-
D
nity partnerships to improve public engagement in clinical trials.
• ighlight and discuss models/methods, both proven and yet to
H
be tried, of public engagement. Address the media’s role in public
engagement.
• escribe novel clinical trial designs (such as adaptive clinical trial
D
designs) that minimize enrollment needs and address treatment
assignment concerns of physicians and their patients.
• nvolve stakeholders in a discussion of moving forward to create a com-
I
prehensive 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:
• rovide a definition of “engagement,” both public and professional,
P
in clinical trials.
• urvey the current landscape in terms of deficiencies in public and
S
professional engagement, and discuss consequences of this lack of
engagement.
• dentify gaps/areas of particular need, desired outcomes of enhanced
I
engagement, and the challenges facing this progress.
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91
APPENDIX A
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:
• hrough case examples, discuss various stakeholder perspectives
T
and efforts focused on public engagement. In case studies, identify
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92 PUBLIC ENGAGEMENT AND CLINICAL TRIALS
primary audiences, key messages, and success or lack of success in
engaging the public.
• resent strategies that foster research interest and participation in
P
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
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93
APPENDIX A
SESSION III: TECHNOLOGIES AND NOVEL
COMMUNICATION APPROACHES
Moderator: Janet Tobias, Mount Sinai School of Medicine
Session Objectives:
• resent innovative technologies/platforms that hold promise for
P
achieving higher levels of public awareness (e.g., clinical trial match -
ing; 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:
• iscuss the role in public engagement of media, health care informa-
D
tion 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
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94 PUBLIC ENGAGEMENT AND CLINICAL TRIALS
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:
• resent novel clinical trial designs currently in use (e.g., adaptive trial
P
designs), their strengths and weaknesses, and the desirability and/or
feasibility of scaling up the widespread use of such designs.
• iscuss the ways in which novel clinical trial designs can enhance
D
public engagement in clinical research and address treatment assign-
ment 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
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95
APPENDIX A
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:
• resent case studies that include a health system perspective on
P
public and professional engagement methods and approaches and
address broader culture and infrastructure/systemic issues.
• ow can health systems develop a culture conducive to conducting
H
clinical trials, including incentives for the careers of health profession-
als, systems approaches to better identify potential enrollees, engage-
ment of referring physician community?
• or a health care delivery system, what are the suggested messages/
F
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?
• ow can academic medical centers create effective community part-
H
nerships 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 Investiga-
tional Network (RAIN), University of Nebraska
10:05-10:20 AM ResearchMatch.org and Other IT Solutions
Paul harris, Vanderbilt University
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96 PUBLIC ENGAGEMENT AND CLINICAL TRIALS
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:
• hat are the most promising methods and messages for public and
W
professional engagement that you heard during this meeting? What
is the likelihood of action? How can they be prioritized?
• hat would be the ideal technology to enhance public and profes-
W
sional engagement?
• hat are the most pressing structural and cultural needs for a local
W
health care system to enhance promotion of public and professional
engagement and participation in clinical trials?
• hat efforts aimed at physicians, researchers, patients, and the
W
broader public will facilitate closing the gap between clinical research-
ers and clinical practitioners?
11:45 AM-12:05 PM The Changing Politics of Clinical Trial
Engagement
larry brown, Columbia University
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97
APPENDIX A
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
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