JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
VOL. 64, NO. 16, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC.
ISSN 0735-1097/$36.00 http://dx.doi.org/10.1016/j.jacc.2014.09.005
LEADERSHIP PAGE
The Future of Clinical Research and the ACC Empowerment Through Registries, Data, and Our Members Patrick O’Gara, MD, FACC, ACC President, Robert A. Harrington, MD, FACC, ACC Board of Trustees
C
linical research provides the evidence base
lack of technology infrastructure as well as clinical
for American College of Cardiology (ACC)
data standards that would facilitate clinical research
documents that help guide clinical practice,
connections among multiple institutions and in-
including expert consensus documents, guidelines,
vestigators. Additionally, there has been little na-
performance measures, and appropriate use criteria.
tional investment into the creation and ongoing
It has been acknowledged that clinical research is
support of sustaining investigator networks, which
critical for the advancement of clinical practice, and
means that most clinical research projects require
increasingly, policy makers are looking to data from
building a network each and every time. This is costly
clinical research to help inform and guide public
and fraught with delays and inefficiencies. Finally,
policy (1). Cardiology is truly an evidence-based spe-
with constraints on public research funding mecha-
cialty, yet only a minority of practice guideline rec-
nisms, there is a great need for more research col-
ommendations is actually supported by the highest
laborations among academics, private practitioners,
quality level of evidence (2). Part of the reason for
and private industry. But intense media coverage of
this discrepancy is due to the many challenges associ-
issues such as conflict of interest and relationships
ated with the conduct of clinical research, especially
with industry has dissuaded many from joining and
in real-world situations among heterogeneous patient
participating in the research process.
populations. Clinical research has become increasingly
A paradox of contemporary society is our ever-
complex, expensive, and difficult to integrate into
increasing demand for evidence to guide clinical
clinical care (3).
practice and decision making while we simulta-
The clinical research workforce depends on assem-
neously struggle to perform the practical aspects of
bling teams of clinicians, quantitative scientists
clinical research. Michael Lauer, MD, Director of the
(including epidemiologists, informaticians, and bio-
Division of Cardiovascular Sciences at the National
statisticians), as well as technical, financial, and oper-
Heart, Lung, and Blood Institute, and his colleagues
ational professionals. Of note, many post-graduate
have called for disruption in the conduct of clinical
residency and fellowship training programs are not
research and have emphasized the need to both
focused on training translational and clinical in-
increase the volume of clinical investigation while
vestigators, and somewhat surprisingly, there is both
also markedly improving the efficiency and ulti-
an insufficient and overly complex clinical research
mately the output of this investigation (4). They and
infrastructure at most academic medical centers.
others have called for better use of EHRs and other
Although there is increasing adoption of electronic
large, coordinated datasets for both more sophisti-
health record (EHR) systems across both private and
cated observational outcomes research as well as the
academic healthcare systems, there is a notable
conduct of pragmatic clinical trials, including use of innovative methods such as EHR point-of-care randomization and registry-based randomized clin-
From the American College of Cardiology, Washington, DC.
ical trials (5). One could argue that the ability to
1752
O’Gara and Harrington
JACC VOL. 64, NO. 16, 2014 OCTOBER 21, 2014:1751–2
Leadership Page
transform data into useful information is among the
implementation science. The organizational structure
most critical aspects of research today.
required to support the data registries is well suited
In the midst of these societal challenges, the ACC is
for helping practices and health systems organize
well suited to play a major leadership role in these
their own clinical research operational infrastruc-
needed disruptions, while also providing real and
tures. NCDR-derived analyses can serve as support
tangible member benefits. Improving the nation’s
for event-rate estimates or for details on medication
clinical research enterprise is completely aligned with
usages or contemporary practice patterns needed in
and supportive of the College’s mission to “transform
the planning of randomized clinical trials.
cardiovascular care and improve heart health” as
Recently, colleagues in Sweden have shown how to
well as its principle to “promote growth, dissemina-
conduct a randomized clinical trial within their own
tion and application of knowledge about cardiovas-
country-wide cardiovascular registries (5). Likewise,
cular medicine.” The investments in building the
the College has collaborated with member investi-
National Cardiovascular Data Registry (NCDR) over
gators (and with support from the National Heart,
more than a decade will now position us to carry out
Lung, and Blood Institute) to pilot use of the CathPCI
our recently crafted strategic plan that focuses on
Registry as the data collection backbone of a ran-
increasing the effectiveness of each member, facili-
domized clinical trial comparing radial and femoral
tating care transformation, improving population
access in women undergoing cardiac catheterization
health, providing purposeful education, shaping
(6). In using the NCDR for clinical investigation, the
health policy through more focused advocacy, and
College has made contributions to the creation of data
leveraging data and information to improve knowl-
standards in cardiovascular disease, and a series of
edge and practice.
documents has been created on data standards that
The College, including in its partnership with the
can be used to facilitate the exchange of healthcare
American Heart Association, needs to support the full
data. Finally, the College’s growth in international
spectrum of science, from basic discovery up through
activities provides additional opportunities for global
population health science. This can be done in part
research collaborations among our many members
through the College’s advocacy for research funding
and institutions.
at the federal level as well as its continued support for
In summary, the thoughtful and appropriate prac-
clinical research that utilizes the College’s clinical
tice of cardiovascular medicine requires an ongoing
practice registries. The College has made scholarly
commitment to the generation of new knowledge
activities a required component of cardiovascular
through discovery and clinical investigation. There
fellowship training. This will be made explicit in the
are additional insights to be gained by facilitating
upcoming revised COCATS (Core Cardiology Training
comparative
Symposium) document. Such a requirement should
management. The ACC is well poised to serve our
help expand the pool of clinical investigators as well
members and society by providing needed support
as help facilitate the interactions between basic sci-
and dedication to cardiovascular research. We have a
entists and clinicians, a desperately needed compo-
responsibility to exercise leadership in this critical
nent of translational research.
enterprise.
effectiveness
research
into
disease
Likewise, the College’s commitment to the cardiovascular care team provides great role modeling
ADDRESS CORRESPONDENCE TO: Dr. Patrick T.
for the multidisciplinary teams required in clinical
O’Gara, American College of Cardiology, 2400 N
investigation. The NCDR provides rich data sources
Street NW, Washington, DC 20037. E-mail: president@
for comparative effectiveness research as well as
acc.org.
REFERENCES 1. Antman EM, Harrington RA. Transforming clinical trials in cardiovascular disease: mission critical for health and economic well-being. JAMA 2012; 308:1743–4.
Rescuing clinical trials in the United States and beyond: a call for action. Am Heart J 2013;165: 837–47. 4. Gordon D, Taddei-Peters W, Mascette A,
2. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC. Scientific evidence underlying the ACC/ AHA Clinical Practice Guidelines. JAMA 2009;301: 831–41.
Antman M, Kaufmann PG, Lauer MS. Publication of trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med 2013;369: 1926–34.
3. Eapen ZJ, Vavalle JP, Granger Harrington RA, Peterson ED, Califf
5. Fröbert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation
CB, RM.
myocardial infarction. N Engl J Med 2013;369: 1587–97. 6. Rao SV, Hess CN, Barham B, et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. J Am Coll Cardiol Intv 2014;7: 857–67.
VOL. 64, NO. 16, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC.
ISSN 0735-1097/$36.00 http://dx.doi.org/10.1016/j.jacc.2014.09.005
LEADERSHIP PAGE
The Future of Clinical Research and the ACC Empowerment Through Registries, Data, and Our Members Patrick O’Gara, MD, FACC, ACC President, Robert A. Harrington, MD, FACC, ACC Board of Trustees
C
linical research provides the evidence base
lack of technology infrastructure as well as clinical
for American College of Cardiology (ACC)
data standards that would facilitate clinical research
documents that help guide clinical practice,
connections among multiple institutions and in-
including expert consensus documents, guidelines,
vestigators. Additionally, there has been little na-
performance measures, and appropriate use criteria.
tional investment into the creation and ongoing
It has been acknowledged that clinical research is
support of sustaining investigator networks, which
critical for the advancement of clinical practice, and
means that most clinical research projects require
increasingly, policy makers are looking to data from
building a network each and every time. This is costly
clinical research to help inform and guide public
and fraught with delays and inefficiencies. Finally,
policy (1). Cardiology is truly an evidence-based spe-
with constraints on public research funding mecha-
cialty, yet only a minority of practice guideline rec-
nisms, there is a great need for more research col-
ommendations is actually supported by the highest
laborations among academics, private practitioners,
quality level of evidence (2). Part of the reason for
and private industry. But intense media coverage of
this discrepancy is due to the many challenges associ-
issues such as conflict of interest and relationships
ated with the conduct of clinical research, especially
with industry has dissuaded many from joining and
in real-world situations among heterogeneous patient
participating in the research process.
populations. Clinical research has become increasingly
A paradox of contemporary society is our ever-
complex, expensive, and difficult to integrate into
increasing demand for evidence to guide clinical
clinical care (3).
practice and decision making while we simulta-
The clinical research workforce depends on assem-
neously struggle to perform the practical aspects of
bling teams of clinicians, quantitative scientists
clinical research. Michael Lauer, MD, Director of the
(including epidemiologists, informaticians, and bio-
Division of Cardiovascular Sciences at the National
statisticians), as well as technical, financial, and oper-
Heart, Lung, and Blood Institute, and his colleagues
ational professionals. Of note, many post-graduate
have called for disruption in the conduct of clinical
residency and fellowship training programs are not
research and have emphasized the need to both
focused on training translational and clinical in-
increase the volume of clinical investigation while
vestigators, and somewhat surprisingly, there is both
also markedly improving the efficiency and ulti-
an insufficient and overly complex clinical research
mately the output of this investigation (4). They and
infrastructure at most academic medical centers.
others have called for better use of EHRs and other
Although there is increasing adoption of electronic
large, coordinated datasets for both more sophisti-
health record (EHR) systems across both private and
cated observational outcomes research as well as the
academic healthcare systems, there is a notable
conduct of pragmatic clinical trials, including use of innovative methods such as EHR point-of-care randomization and registry-based randomized clin-
From the American College of Cardiology, Washington, DC.
ical trials (5). One could argue that the ability to
1752
O’Gara and Harrington
JACC VOL. 64, NO. 16, 2014 OCTOBER 21, 2014:1751–2
Leadership Page
transform data into useful information is among the
implementation science. The organizational structure
most critical aspects of research today.
required to support the data registries is well suited
In the midst of these societal challenges, the ACC is
for helping practices and health systems organize
well suited to play a major leadership role in these
their own clinical research operational infrastruc-
needed disruptions, while also providing real and
tures. NCDR-derived analyses can serve as support
tangible member benefits. Improving the nation’s
for event-rate estimates or for details on medication
clinical research enterprise is completely aligned with
usages or contemporary practice patterns needed in
and supportive of the College’s mission to “transform
the planning of randomized clinical trials.
cardiovascular care and improve heart health” as
Recently, colleagues in Sweden have shown how to
well as its principle to “promote growth, dissemina-
conduct a randomized clinical trial within their own
tion and application of knowledge about cardiovas-
country-wide cardiovascular registries (5). Likewise,
cular medicine.” The investments in building the
the College has collaborated with member investi-
National Cardiovascular Data Registry (NCDR) over
gators (and with support from the National Heart,
more than a decade will now position us to carry out
Lung, and Blood Institute) to pilot use of the CathPCI
our recently crafted strategic plan that focuses on
Registry as the data collection backbone of a ran-
increasing the effectiveness of each member, facili-
domized clinical trial comparing radial and femoral
tating care transformation, improving population
access in women undergoing cardiac catheterization
health, providing purposeful education, shaping
(6). In using the NCDR for clinical investigation, the
health policy through more focused advocacy, and
College has made contributions to the creation of data
leveraging data and information to improve knowl-
standards in cardiovascular disease, and a series of
edge and practice.
documents has been created on data standards that
The College, including in its partnership with the
can be used to facilitate the exchange of healthcare
American Heart Association, needs to support the full
data. Finally, the College’s growth in international
spectrum of science, from basic discovery up through
activities provides additional opportunities for global
population health science. This can be done in part
research collaborations among our many members
through the College’s advocacy for research funding
and institutions.
at the federal level as well as its continued support for
In summary, the thoughtful and appropriate prac-
clinical research that utilizes the College’s clinical
tice of cardiovascular medicine requires an ongoing
practice registries. The College has made scholarly
commitment to the generation of new knowledge
activities a required component of cardiovascular
through discovery and clinical investigation. There
fellowship training. This will be made explicit in the
are additional insights to be gained by facilitating
upcoming revised COCATS (Core Cardiology Training
comparative
Symposium) document. Such a requirement should
management. The ACC is well poised to serve our
help expand the pool of clinical investigators as well
members and society by providing needed support
as help facilitate the interactions between basic sci-
and dedication to cardiovascular research. We have a
entists and clinicians, a desperately needed compo-
responsibility to exercise leadership in this critical
nent of translational research.
enterprise.
effectiveness
research
into
disease
Likewise, the College’s commitment to the cardiovascular care team provides great role modeling
ADDRESS CORRESPONDENCE TO: Dr. Patrick T.
for the multidisciplinary teams required in clinical
O’Gara, American College of Cardiology, 2400 N
investigation. The NCDR provides rich data sources
Street NW, Washington, DC 20037. E-mail: president@
for comparative effectiveness research as well as
acc.org.
REFERENCES 1. Antman EM, Harrington RA. Transforming clinical trials in cardiovascular disease: mission critical for health and economic well-being. JAMA 2012; 308:1743–4.
Rescuing clinical trials in the United States and beyond: a call for action. Am Heart J 2013;165: 837–47. 4. Gordon D, Taddei-Peters W, Mascette A,
2. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC. Scientific evidence underlying the ACC/ AHA Clinical Practice Guidelines. JAMA 2009;301: 831–41.
Antman M, Kaufmann PG, Lauer MS. Publication of trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med 2013;369: 1926–34.
3. Eapen ZJ, Vavalle JP, Granger Harrington RA, Peterson ED, Califf
5. Fröbert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation
CB, RM.
myocardial infarction. N Engl J Med 2013;369: 1587–97. 6. Rao SV, Hess CN, Barham B, et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. J Am Coll Cardiol Intv 2014;7: 857–67.
