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1
Priorities for Engaging the Public
in the Clinical Research Enterprise
WORKSHOP INTRODUCTION
A recent editorial in the Journal of the American Medi-
cal Association noted that the clinical research enterprise is
in crisis (Rosenberg, 2003~. The accompanying article iden-
tified enhancing public participation in the Clinical Research
Enterprise as a top priority for ensuring that the Clinical
Research Enterprise is functioning optimally (Sung et al.,
2003~. Key concerns regarding public involvement in clini-
cal research include conflicts of interest, diversity of partici-
pation, community involvement, safety, and privacy. Be-
cause participatory-based research methods involve
members of the public in all stages of the design and conduct
of research, there is greater opportunity to address diversity
of participation, community involvement, privacy, and other
concerns. Training for clinical researchers and participants
about the ethical conduct of research, including policies and
procedures to monitor financial conflicts of interest, also
have been suggested as ways to address these concerns
(IOM, 2003; Schwetz and Dobs, 2002; Sung et al., 2003~.
For these reasons, enhancing the role of the public in the
Clinical Research Enterprise was the focus of this workshop.
Opening the workshop, Mary Woolley, M.A., President
of Research!America, noted that members of the public-
patients, healthy participants, family members, and others-
are very willing to take part in the research process. Re-
search, she said, offers hope, which is a powerful motivator
for the public to work with the research community.
Researchers, too, are committed to speeding up the re-
search process and making it as safe as possible through ac-
countability and a willingness to learn from the public and to
answer questions about research. Ms. Woolley cautioned,
though, that the research community must stay out of the
lecture mode and out of the habit of thinking that researchers
know what the public "needs to know." Instead, they should
listen to and learn from members of the public, she said.
Numerous polls have shown that the public believes that
s
supporting research is a very high national priority, as re-
flected by the bipartisan commitment to double the National
Institutes of Health (NIH) budget in five years. However,
Ms. Woolley pointed out that only about half the members
of the public can name a single place where research is con-
ducted (Charlton Research Company, 2002a). In addition,
only about 2 percent recognize the NIH and its purpose
(Charlton Research Company, 2002b). Ms. Woolley stated
that members of the public want to be involved and will
listen and learn as quickly as possible, but they do not want
to be patronized. The public will be respectful, but they will
not be docile; they will help researchers because all of us
want research to succeed.
The research community has not been very successful
in attracting patients to participate in clinical trials only 4
percent of adult cancer patients are enrolled in clinical trials,
commented Ms. Woolley. Research is an enterprise that most
people have had no contact with, and in the past, researchers
appear to have liked it that way, thinking that people without
scientific training could not understand, much less intellec-
tually contribute to, their research.
Patient engagement should inform and saturate every
aspect of research, from formulating a research agenda to
study design, to study review, to oversight at all levels, to
dissemination and to translation to practice, she noted. This
requires making a seat at the table for not just one but for
several nonscientists.
According to Ms. Woolley, the purpose of the work-
shop was not to determine a rigid definition of what patient-
centered research should or should not be, but rather to iden-
tify and agree to act upon ways in which the research
community can more actively and more productively engage
the public.
Ms. Woolley concluded by describing the ideal outcome
of engaging the public in clinical research. At that point, she
said, when a member of the public asks a researcher what
she does, the researcher will respond, "I am a researcher. I
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6
work for you. I serve the public's interest." And the ques-
tioner will not say, "What are you talking about?" but in-
stead will reply, "Yes, I know how research works for me;
tell me how I can do more to support research."
PRIORITIES FOR ENGAGING THE PUBLIC
Since National Institutes of Health (NIH) Director Dr.
Elias Zerhouni began his tenure at NIH in May 2002, he has
quickly confronted a number of challenges facing the Insti-
tutes. At the workshop, he made clear that engaging the pub-
lic in the clinical research enterprise is a top priority.
According to Dr. Zerhouni, engaging the public must
be considered not as a nice gesture, but as a "strategic im-
perative" for a number of reasons. First, translating basic
advances into clinical reality is increasingly difficult. Sec-
ond, discoveries and clinical validation must be accelerated
to meet the rapid growth rate of healthcare needs and expen-
ditures. As a percentage of GDP, the United States has the
highest expenditure on health care in the world, and that rate
is increasing (Levis et al., 2003~. Third, clinical approaches
must be more efficient, by an order of magnitude, than cur-
rent ones. Finally, public support and participation are es-
sential, because these goals cannot be achieved without the
public's help and understanding. Dr. Zerhouni pointed out
that public participation in AIDS trials and coronary heart
disease research has led to declines in the number of deaths
from those diseases.
"There is no doubt that if we just keep practicing medi-
cine as we know it today, there is very little that we can see
that will change the population dynamics of health and dis-
ease in our country," Dr. Zerhouni noted. He listed three
major priorities to further engage the public in the clinical
research enterprise: trust, ongoing bi-directional communi-
cation, and education.
Trust
While trust, defined by Dr. Zerhouni as "the ability to
predict someone's behavior," has been an issue of concern
for some time, it is now "the number one issue, and we need
to tackle it and tackle it fully," he said. Retaining the trust of
the public requires transparency, predictability, respect, qual-
ity assurance, and a vibrant and respected national Clinical
Research Enterprise.
In Dr. Zerhouni's view, there are many aspects of the
"There is no Doubt that if we just keep practicing medicine as we
know it today, there is very little that we can see that will change
the population Dynamics of health and Disease in our country."
Elias Zerhouni
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
relationship between the public and the Clinical Research
Enterprise that are not sufficiently transparent. He cited con-
flict of interest as one example, noting that conflicts must be
addressed in a manner that is transparent both in reality and
in the perception of the public. An actual lack of transpar-
ency can foster distrust, but so can the perception that there
is a lack of transparency.
Dr. Zerhouni commented that maintaining a cadre of
scientists and investigators who possess an invariant set of
core values is important to foster predictability. Currently, in
Dr. Zerhouni's view, the public believes that the core values
are variable or not as strong as they should be within the
Clinical Research Enterprise. He noted that a system cannot
be built on regulations alone if it is to gain the trust of the
public.
``lt is no longer possible for us to tell people what research we are
going to co from the top. We need to have collaboration; other-
wise, you will not get the results that you want from the Clinical
Research Enterprise."
Elias Zerhouni
..........................................................................................................................................................................................................................................................
Respect also is essential if the Clinical Research Enter-
prise is to retain the trust of the public, but the question is
how to create the necessary respectful relationship. Privacy
issues are one component of this relationship. Furthermore,
with such a large Clinical Research Enterprise, there is a
need for quality assurance mechanisms, including the
credentialing of investigators, according to Dr. Zerhouni.
Dr. Zerhouni noted that the current system is not work-
ing properly. In his view, the problem cannot be fixed
through unitary solutions, but will require a systems engi-
neering approach, including an assessment of the relation-
ships in the system between patient advocacy groups, the
public, academic health centers, and community physicians.
He noted that the ability of the United States to extract clini-
cal research data from its investment in health care is not
comparable to that of other countries, such as Sweden or
England, because of a fragmented health care system in the
United States and a lack of an interoperable information in-
frastructure.
Bi-Directional Communication
Referring to bi-directional communication between the
research community and the public, Dr. Zerhouni said, "It is
no longer possible for us to tell people what research we are
going to do from the top. We need to have collaboration;
otherwise, you will not get the results that you want from the
Clinical Research Enterprise." He noted that public input at
NIH is protean, and currently relies primarily on one-way
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PRIORITIES FOR ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
communication. The Council of Public Representatives
(COPR) is an example of public input. Dr. Zerhouni believes
that there is a need to ensure that patient advocacy groups
are involved in collaboration early in the process, because
they can accelerate the pace of research and can make it
more effective and cogent.
The United States public is diverse, and therefore, there
is no one-size-fits-all solution. There are many, many ways
to engage the public, but there has not been enough scientific
study on the most effective ways to interact with the public,
Dr. Zerhouni commented. Communication must be adapted
to each segment of the public and be sensitive to trusted
intermediaries such as doctors, patient advocacy groups,
churches, and the media, he said. Dr. Zerhouni cited the
media as a particularly important conduit for information. In
addition, he noted that some members of the public, such as
minorities and underserved people, are left out; they need to
be included in the process.
Physicians are essential for a vibrant Clinical Research
Enterprise, but the proportion of academic physicians con-
ducting and translating research has decreased since 1980
6 percent of doctors reported research as their primary career
activity in 1980 versus 2 percent in 2000~ according to data
7
KEY ISSUES FACING THE CLINICAL RESEARCH
ENTERPRISE
Asked about the challenge of translating research dis-
coveries into practice, Dr. Zerhouni responded that the prob-
lem is complex, and that there is a need to address the eco-
system the relationship of academic health centers and
communities to each other. He added that there already is a
deficit (of practitioners, funds, etc.) facing clinical practice,
without the additional resources needed to translate research
into practice.
He noted that often the weak link in the Clinical Re-
search Enterprise is translating findings into practice, in part
because economic terms do not support this. Researchers
make their discoveries and then move on to the next project,
because this is where the funding is. Referring to the need to
address clinical research as an enterprise, Dr. Zerhouni com-
mented that the elements of the discussion will have to in-
clude how to standardize and build a common infrastructure
across the country and how to serve the country better in
terms of spending on health care that is not effectively edu-
cating doctors about what is right for patients.
The public and private sectors should not be completely
=~ separate but appropriate safeguards are essentialto earn
from the Medical Marketing Service presented by Dr. ~ . '
Zerhouni. "So, no matter how you slice it, we are in a crisis
mode," said Dr. Zerhouni.
Education
Dr. Zerhouni also commented that currently, there is a
need to better educate the public about clinical research. He
also noted that a well-informed public is supportive of clini-
cal research and that public trust is based on education. He
called upon clinical researchers to ensure that information
given to the public is accurate and not misleading. He cau-
tioned against creating false expectations in the public on the
basis of incomplete information and called on NIH and oth-
ers to "take the highest road possible on these issues."
``Engaging the public is a major priority, it is a national priority, it
is not an option."
Elias Zerhouni
Dr. Zerhouni cited the Internet as one source to educate
the public. Compared to other federal dot.gov websites, NIH
is the most visited site in the country, with around 3.6-4.6
million users per month in 2002, according to NetRatings,
Inc. "Engaging the public is a major priority, it is a national
priority, it is not an option," said Dr. Zerhouni. To do this,
there is a need to move from an institution-centric and inves-
tigator-centric system to one that is patient-centric.
public trust, according to Dr. zerhoun~. belt Is a symbiotic
relationship, and we will have to do as well as we can to
make sure that you have the ability to translate those discov-
eries into reality," he said.
Regarding the perceived bias in funding of clinical ver-
sus basic research, Dr. Zerhouni countered, that the numbers
do not indicate to him that there is a cultural bias. In fact,
because study sections have been redesigned to facilitate the
review of clinical research by a critical mass of peers, the
success rate of clinical applicants is now similar to that of
other applicants for funding. He further commented that he
wants a balanced portfolio that looks at the impact of the
research that is being done.
Dr. Zerhouni, responding to a question about NIH fund-
ing more outcomes research, commented that measuring to
ensure that the modifications to healthcare patterns are more
effective than those currently in use is very desirable. How-
ever, he added that while this is important, it is not the mis-
sion of the NIH to support a lot of outcomes research, unless
there is potential to make a quantum change in the way clini-
cal research is conducted.The clinical research system needs
to be reengineered in a multidisciplinary fashion to best serve
the country, he said. Referring to input from advocacy groups
to the NIH, Dr. Zerhouni said that he is very impressed with
the amount of interaction that occurs: The Institutes are very
open. They have public representation on their Councils. "I
don't have that sense of an ivory tower fortress from the
Institutes," he commented. However, he noted that cross-
Institute coordination is more complicated.
Furthermore, he commented that earmarking congres-
sional funds is detrimental, and the groups that focus solely
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8
"fThere is a need to] work with patient advocacy groups, especial Iy
when you can have combinations of advocacy groups with a scien-
tific agencathat really understand the spectrum of research activi-
ties that need to occur for progress in any one Disease to happen."
Elias Zerhouni
on one disease or outcome are not necessarily helpful to the
larger process. There is a need to "work with patient advo-
cacy groups, especially when you can have combinations of
advocacy groups with a scientific agenda that really under-
stand the spectrum of research activities that need to occur
for progress in any one disease to happen," he commented.
REFERENCES
Charlton Research Company for Research!America. 2002a. Public Doesn't
Know Where Research Is Conducted. Data from Research!America
polls 1998-2002.
Charlton Research Company for Research!America. 2002b. Aggregate
2002: Most Do Not Recognize NIH. Data presented by
Research!America.
Institute of Medicine. 2003. Responsible Research: A Systems Approach to
Protecting Research Participants. National Academies Press: Wash-
ington, DC.
Levit K, et al. 2003. Trends in U.S. health care spending, 2001. Health
Affairs 22(1):154-164.
Rosenberg RN.2003. Translating biomedical research to the bedside. JAMA
289: 1305-1306.
Schwetz B. Dobs A. 2002. Streamlining the Clinical Research Enterprise.
Journal of Investigative Medicine 50(5):22-26.
Sung N. et al. 2003. Central challenges facing the national clinical research
enterprise. JAMA 289:1278-1287.
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
Representative terms from entire chapter:
charlton research
