The Future of Clinical Research and the ACC

Empowerment Through Registries, Data, and Our Members

Clinical research provides the evidence base for American College of Cardiology (ACC) documents that help guide clinical practice, including expert consensus documents, guidelines, performance measures, and appropriate use criteria. It has been acknowledged that clinical research is critical for the advancement of clinical practice, and increasingly, policy makers are looking to data from clinical research to help inform and guide public policy (1). Cardiology is truly an evidence-based specialty, yet only a minority of practice guideline recommendations is actually supported by the highest quality level of evidence (2). Part of the reason for this discrepancy is due to the many challenges associated with the conduct of clinical research, especially in real-world situations among heterogeneous patient populations. Clinical research has become increasingly complex, expensive, and difficult to integrate into clinical care (3).

The clinical research workforce depends on assembling teams of clinicians, quantitative scientists (including epidemiologists, informaticians, and biostatisticians), as well as technical, financial, and operational professionals. Of note, many post-graduate residency and fellowship training programs are not focused on training translational and clinical investigators, and somewhat surprisingly, there is both an insufficient and overly complex clinical research infrastructure at most academic medical centers.

Although there is increasing adoption of electronic health record (EHR) systems across both private and academic healthcare systems, there is a notable lack of technology infrastructure as well as clinical data standards that would facilitate clinical research connections among multiple institutions and investigators. Additionally, there has been little national investment into the creation and ongoing support of sustaining investigator networks, which means that most clinical research projects require building a network each and every time. This is costly and fraught with delays and inefficiencies. Finally, with constraints on public research funding mechanisms, there is a great need for more research collaborations among academics, private practitioners, and private industry. But intense media coverage of issues such as conflict of interest and relationships with industry has dissuaded many from joining and participating in the research process.

A paradox of contemporary society is our ever-increasing demand for evidence to guide clinical practice and decision making while we simultaneously struggle to perform the practical aspects of clinical research. Michael Lauer, MD, Director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, and his colleagues have called for disruption in the conduct of clinical research and have emphasized the need to both increase the volume of clinical investigation while also markedly improving the efficiency and ultimately the output of this investigation (4). They and others have called for better use of EHRs and other large, coordinated datasets for both more sophisticated observational outcomes research as well as the conduct of pragmatic clinical trials, including use of innovative methods such as EHR point-of-care randomization and registry-based randomized clinical trials (5). One could argue that the ability to transform data into useful information is among the most critical aspects of research today.

In the midst of these societal challenges, the ACC is well suited to play a major leadership role in these needed disruptions, while also providing real and tangible member benefits. Improving the nation’s clinical research enterprise is completely aligned with and supportive of the College’s mission to “transform cardiovascular care and improve heart health” as well as its principle to “promote growth, dissemination and application of knowledge about cardiovascular medicine.” The investments in building the National Cardiovascular Data Registry (NCDR) over more than a decade will now position us to carry out our recently crafted strategic plan that focuses on increasing the effectiveness of each member, facilitating care transformation, improving population health, providing purposeful education, shaping health policy through more focused advocacy, and leveraging data and information to improve knowledge and practice.

The College, including in its partnership with the American Heart Association, needs to support the full spectrum of science, from basic discovery up through population health science. This can be done in part through the College’s advocacy for research funding at the federal level as well as its continued support for clinical research that utilizes the College’s clinical practice registries. The College has made scholarly activities a required component of cardiovascular fellowship training. This will be made explicit in the upcoming revised COCATS (Core Cardiology Training Symposium) document. Such a requirement should help expand the pool of clinical investigators as well as help facilitate the interactions between basic scientists and clinicians, a desperately needed component of translational research.

Likewise, the College’s commitment to the cardiovascular care team provides great role modeling for the multidisciplinary teams required in clinical investigation. The NCDR provides rich data sources for comparative effectiveness research as well as implementation science. The organizational structure required to support the data registries is well suited for helping practices and health systems organize their own clinical research operational infrastructures. NCDR-derived analyses can serve as support for event-rate estimates or for details on medication usages or contemporary practice patterns needed in the planning of randomized clinical trials.

Recently, colleagues in Sweden have shown how to conduct a randomized clinical trial within their own country-wide cardiovascular registries (5). Likewise, the College has collaborated with member investigators (and with support from the National Heart, Lung, and Blood Institute) to pilot use of the CathPCI Registry as the data collection backbone of a randomized clinical trial comparing radial and femoral access in women undergoing cardiac catheterization (6). In using the NCDR for clinical investigation, the College has made contributions to the creation of data standards in cardiovascular disease, and a series of documents has been created on data standards that can be used to facilitate the exchange of healthcare data. Finally, the College’s growth in international activities provides additional opportunities for global research collaborations among our many members and institutions.

In summary, the thoughtful and appropriate practice of cardiovascular medicine requires an ongoing commitment to the generation of new knowledge through discovery and clinical investigation. There are additional insights to be gained by facilitating comparative effectiveness research into disease management. The ACC is well poised to serve our members and society by providing needed support and dedication to cardiovascular research. We have a responsibility to exercise leadership in this critical enterprise.

• American College of Cardiology Foundation