Click here to read the original article in International Clinical Trials magazine.
Written by
Thomas E. Waggoner, DO, FACC, FSCAI, FSVM, RPVI
Director, Cardiovascular Research, Pima Health
Cardiovascular disease is the world’s leading cause of death, yet the trials shaping its treatment draw from a narrow slice of the population living with it. Community cardiology practices offer sponsors faster enrollment, more representative populations and a model that reaches patients where they already receive care.
The Disease Responsible for One in Every Three Deaths Worldwide
According to the World Health Organization, cardiovascular disease is responsible for an estimated 19.8 million deaths annually, representing approximately 32% of all global deaths.¹ In the US, it affects nearly half of all adults and its economic burden runs into hundreds of billions of dollars annually.² Projections suggest that ischaemic heart disease and stroke will hold their position as the leading cardiovascular killers well into 2050, sustained by ageing populations and the entrenched prevalence of hypertension, obesity and metabolic disease.³
Against that backdrop, the research response has been significant. Cardiovascular medicine has produced some of the most influential trials in modern medicine, from pivotal statin and anticoagulation studies to recent work on SGLT2 inhibitors in heart failure and evolving evidence in preventive coronary intervention. In many respects, cardiology led the transition to evidence-based clinical practice.
Yet that evidence comes overwhelmingly from academic medical centres, drawn from patient populations that do not broadly represent the true scope of those living with cardiovascular disease. This is not a uniform condition. Heart failure alone reflects an intersection of genetic, metabolic and coronary factors that vary across individuals and populations. Trials that enrol from a single type of care setting further narrow that complexity, and the resulting evidence carries limitations that clinical guidelines rarely acknowledge.
Why Trials Historically Cluster at Academic Centres
The concentration of cardiovascular clinical trials at major research hospitals reflects where infrastructure was invested in previous decades. Over time, these institutions assembled a combination of resources, capabilities and professional networks built around investigation. Dedicated research staff, an established institutional review board, imaging capabilities, biostatistical support and regulatory expertise exist under one roof, offering sponsors a conservative bet on a centre’s ability to activate and execute a study.
The trade-off has become increasingly visible. Academic medical centres carry significant administrative overhead and their research infrastructure can be slow to activate, constrained by institutional bureaucracy and resistant to adapting quickly when operational needs shift. Sponsors accustomed to working with these sites often accept long activation timelines and higher per-patient costs as standard, without fully accounting for what a nimbler community site network might offer in their place.
Consequently, patients who receive care outside the academic ecosystem are rarely offered the opportunity to participate. The majority of Americans living with coronary artery disease, heart failure, atrial fibrillation and hypertension seek treatment in private and health-system-affiliated outpatient practices that serve far wider geographic, socioeconomic and demographic populations than the university hospitals anchoring most trial networks. Evidence generated from that subset may not represent real-world patient populations or accurately reflect therapeutic effects across the full spectrum of cardiovascular disease.
The Impact on Sponsors
Enrolment is the single largest driver of trial timelines and academic centres, despite their resources, routinely struggle to meet recruitment targets on schedule. Narrow patient populations, high screening failure rates and institutional overhead combine to produce slower activation, higher per-patient costs and data that may not translate cleanly to the broader populations that approved therapies will ultimately treat.
Inclusion and exclusion criteria have become increasingly stringent, often excluding patients who would otherwise be well suited for a trial. Given the heterogeneity of cardiac conditions, criteria calibrated narrowly enough to produce a clean trial population frequently exclude the complex, multimorbid patients most prevalent in community practice. That gap between trial population and real-world patients complicates regulatory submissions and raises questions about post-approval generalisability.
Sponsors managing development portfolios across heart failure, coronary disease and arrhythmia have a clear incentive to assess where eligible patient populations actually live and receive care, and to build site networks that reflect that reality. Community practices that treat high volumes of these patients offer a materially different value proposition, one that academic centres, by structure and geography, are not positioned to replicate.
The Reality of Community Research
Community-based cardiology practices that express interest in running trials encounter a gap between intention and execution. The cost of assembling a qualified research team is significant, and the operational demands of a research programme sit atop already full clinical schedules. Research coordination requires trained staff to manage informed consent, eligibility screening, protocol adherence and quality/regulatory documentation.
The physician’s involvement can be equally demanding. A highly engaged cardiologist who commits to learning protocols, educating patients and building relationships with sponsors to source new study opportunities takes on this new level of expertise while maintaining a full clinic schedule. Physicians are expected to step into a role that serves as a “general manager” to lead a sustainable, scalable and even profitable research ancillary.
The financial model presents its own dynamics. Academic research runs on grants, indirect cost recovery and institutional investment. Per-patient payments from sponsors generate revenue, but the clinic must make an upfront investment in staffing, systems and equipment before that revenue arrives.
That staffing challenge is compounded by high turnover. Research coordinators turn over at rates exceeding 30%, and more than half have fewer than three years of experience.⁴ High turnover disrupts patient relationships, strains protocol continuity and forces practices into recurring training costs that erode profitability. Sites that invest in structured operational support are better positioned to enrol quickly and maintain study quality over time.
US Heart and Vascular, a community cardiology group with a broad patient footprint in Arizona, Texas and several other states, made the deliberate decision to expand its clinical research capabilities with these operational realities in mind. The practice recognised that active trial participation extended the scope of care it could offer patients while reinforcing its standing within the local and regional cardiology referral network.
Community-based practices and their clinicians that succeed in building research programmes treat participation not as an administrative burden but as a treatment option, offering patients early access to therapies that may not be available through standard care for years.
Why Community Sites Are Advancing the Field
Community clinics offer three distinct advantages that academic sites struggle to replicate at scale.
The first is access to diverse, real-world patient populations. Heart failure with preserved ejection fraction, chronic coronary disease and poorly controlled hypertension are conditions where the eligible population is large and dispersed across outpatient settings. Sponsor programmes that activate community sites for these indications often find that per-site recruitment efficiency compares favourably to relying exclusively on academic centres with higher overhead and smaller catchment areas.
The second is speed. Community practices, when supported operationally, activate faster, screen more efficiently across broader patient panels and adjust more readily to protocol requirements than institutions carrying layers of administrative process.
The third is patient trust. Participating in a trial at a familiar practice, under the care of a physician who knows the patient’s history, substantially lowers the logistical and psychological barriers that prevent willing candidates from enrolling.
The clinical impact of that combination is real. A community physician in Tucson, Arizona, was the only provider in the state able to offer a transcatheter heart valve to an 84-year-old patient through an active clinical research protocol. That access existed because the practice had built the research infrastructure to participate, not because the patient happened to live near an academic centre.
A Research Ecosystem Built for the Real World
The cardiovascular trial landscape will not shift through isolated site-level effort. The structural changes needed operate at the intersection of sponsor strategy, site capability and operational support.
For sponsors, the opportunity lies in building site networks that look beyond their default reliance on major academic centres, identifying community practices with the patient populations to enrol efficiently, the physician commitment to execute protocols consistently and the operational backbone to sustain that execution. Centralised operational support, whether through embedded staff, shared service models or sponsor-provided resources, is the most direct lever to improve site performance and maintain enrolment quality.
For physicians and practices, sustainable trial participation rests on three interdependent conditions: experienced, engaged teams who execute protocols while building patient trust; efficient, scalable operations with structured workflows that allow multiple studies to run without compromising data quality; and financial and study-fit alignment, ensuring the studies a practice takes on match its patient population and remain operationally achievable.
For patients, the value is direct. Trial participation is consistently associated with better health outcomes, reflecting the closer monitoring and protocol-driven care that studies require. Patients may also gain access to therapies years before regulatory approval, a meaningful advantage for those with advanced or treatment-refractory disease.
Heart disease does not confine itself to academic medical centres. Expanding community cardiology practices as genuine research partners, with the operational infrastructure to sustain them, accelerates drug development, produces more representative clinical evidence, and positions research as a model that the scale and diversity of cardiovascular disease has long required.
References
- World Health Organization. Cardiovascular diseases (CVDs). Available at: who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
- Centers for Disease Control and Prevention. Chronic Disease Facts and Statistics. Available at: cdc.gov/chronic-disease/data-research/facts-stats
- Global burden projections for cardiovascular disease through 2050. Available via PubMed.
- Research coordinator workforce and turnover study. Available at Walden University ScholarWorks.
About the Author
Thomas Waggoner, DO, FACC, FSCAI, FSVM
Thomas Waggoner is a structural interventional cardiologist, vascular specialist and principal investigator at Pima Health Heart and Vascular in Tucson, Arizona, where he serves as medical director of the structural heart disease and cardiovascular research programmes at Tucson Medical Center. He is a Fellow of the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society for Vascular Medicine, and is a registered physician in Vascular Interpretation.
Thomas also serves as a US Heart and Vascular physician champion for Clinical Research, partnering with Iterative Health on strategic initiatives. He leads multiple ongoing clinical studies and serves as a national physician proctor for complex transcatheter cardiac devices, with a record of first-in-patient device implants across Southern Arizona.
He trained at the University of New England College of Osteopathic Medicine and completed his interventional, structural heart and endovascular fellowship at Deborah Heart and Lung Institute in Pemberton Township, New Jersey.
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