Built-in patient flow: why an in-house specialty cardiology practice out-enrolls referral-network trial sites

Ask a cardiovascular sponsor why a U.S. site missed enrollment and you will hear a familiar story. The site was activated. The IRB letter was framed. The investigator was enthusiastic on the feasibility call. Then months passed and the screening log stayed empty. The patients were never inside that investigator's daily workflow. They were supposed to arrive through a referral network that had no reason to prioritize the protocol.

I'm Julio Martinez-Clark, CEO of Amavita Research. We run cardiovascular clinical trials from Miami with investigators who practice inside amavita Heart and Vascular Health®. This article explains why an in-house specialty cardiology practice out-enrolls a referral-dependent model for the protocols we take on — and where that advantage stops.

How referral-network recruitment fails quietly

Traditional site models often depend on physicians who do not see the trial patient as part of routine care. A coordinator sends eligibility criteria to a community list. Busy clinicians mean to refer. Charts sit. Competing duties win. By the time someone reviews a potential subject, the visit window has moved or the patient has already been treated outside the protocol.

Published site-performance research has long shown that a meaningful share of activated investigative sites enroll no patients at all, and a larger share under-enroll relative to their targets. Exact percentages vary by era and study set; the operational lesson does not. Activation is not enrollment. A site without a built-in patient pathway is a cost center with a plaque.

The hidden cost shows up in sponsor timelines: second waves of site adds, protocol amendments to broaden criteria, and rescue budgets that were never in the original award. None of that appears on the feasibility questionnaire when everyone is still optimistic.

The in-house practice pipeline

Amavita Research is embedded next to an active Miami cardiovascular practice, not parked across town waiting for referrals. Investigators see cardiology patients in clinic and in affiliated procedure settings as part of ordinary care. When a protocol opens, pre-screening starts from patients already in that care stream — consults, diagnostic workups, follow-ups — instead of from a cold referral email.

What that changes:

• Point-of-care identification. Eligibility is checked while the clinical problem is being managed, not weeks later from a forwarded PDF.
• Investigator continuity. The physician who knows the patient's history is often the same physician who serves as investigator or sub-investigator on the trial.
• Faster chart truth. Recent labs, imaging and medication lists are already in the practice record, so screen failures happen early instead of at a wasted baseline visit.
• Trust in the consent conversation. Patients hear about research from a team they already see for heart care, in the languages we use every day in South Florida.

The practice has seen more than 16,000 cardiovascular patients across the last three years. That figure is a panel-size fact for feasibility planning, not a promise that 16,000 people match your inclusion criteria. Indication, window and competing trials still decide the real funnel. What the panel gives you is a place to look first.

South Florida demographics and diversity planning

FDA diversity action plans ask sponsors to show how they will enroll populations that match the disease burden. South Florida's patient mix includes a large Hispanic and Caribbean community that many U.S. cardiovascular programs struggle to reach through academic referral chains alone.

Because those patients are already in the practice, we do not treat diversity as a separate marketing campaign bolted on after site activation. It is a property of the care population. We have written more on that topic in our note on FDA diversity action plans and cardiovascular site selection. Sponsors still have to write a protocol that allows those patients in; a diverse city cannot fix an inclusion criterion that excludes them.

What "in-house" does not mean

I want the limits stated clearly.

• We are a cardiovascular research site. We do not claim current non-cardiovascular therapeutic portfolios.
• The model is a dedicated research operation tied to a specialty cardiology practice and an affiliated cardiovascular ambulatory surgery center in Kendall.
• In-house flow improves screening. It does not erase screen-fail rates, washouts or patient choice. People decline. Criteria bite. Competing studies exist.
• If your protocol needs a population we do not see — a narrow genotype, a pediatric cohort, a non-CV indication — we will say so at feasibility instead of pretending the panel covers it.

Startup and coordinating operations

Enrollment advantage only matters if startup does not erase it. Our operating pattern:

• Dedicated study coordinators who live inside cardiovascular workflows rather than rotating across unrelated specialties.
• Principal investigators and sub-investigators who are practicing cardiologists in the affiliated practice, including interventional, structural and electrophysiology coverage as the protocol requires.
• IRB and regulatory packages prepared on a parallel track with contract and budget work so the screening clock starts when the site is actually ready, not when the last signature happens to arrive.
• Quality framework under ICH-GCP E6(R3), with Amavita Research holding IAOCR GCSA certification.

Feasibility questions come to me and to our chief operations officer, Nereisy Alonso. We would rather decline a protocol that does not fit than accept one that will sit at zero enrollments.

How sponsors should pressure-test any "high-enrolling" site

When a site tells you it can enroll, ask for:

1. Where the patients come from this month — practice panel, hospital census, or external referrals — with percentages.
2. How many patients in the indication were seen in the last 12 months, and how many would have met draft criteria.
3. Which investigator will actually see those patients during the enrollment window.
4. What competing cardiovascular protocols are open at the same site.
5. How screen fails are documented and reported in the first 60 days.

If the answers all point to "our referring doctors are very supportive," you are buying hope. If the answers point to named cardiology practice sessions, procedure lists and a living chart review process, you are buying a pathway.

A week in the life of an in-house screen

Here is what enrollment work looks like when the practice and the research team share a building and a schedule. Coordinators pull a short list of patients with upcoming cardiology visits whose charts suggest the indication. Investigators see those patients for clinical care. If the patient is interested, the research conversation starts the same day or at a scheduled follow-up, with bilingual consent support when Spanish or another language is the patient's preference. Screen procedures that can be combined with clinically indicated tests are scheduled on purpose, so the patient is not asked to return three times for information the chart already holds.

Compare that to a referral model where the first research contact is a phone call from a coordinator the patient has never met, scheduled two weeks after a specialist visit at another office. Both models can work. Only one of them sits inside the care pathway that already produces cardiovascular diagnoses in volume.

Where this model fits best

In-house cardiology recruitment is a strong fit for outpatient and same-day cardiovascular protocols, device follow-up endpoints, heart-failure and hypertension programs that draw from general cardiology panels, and peri-procedural studies tied to the affiliated ASC. It is a weak fit for protocols that depend on rare inpatient-only presentations we do not see, or on therapeutic areas outside cardiovascular care.

For early-phase work that also needs telemetry-monitored observation beds, read our separate description of the Phase 1 unit inside the Kendall ASC. Recruitment and monitoring are related capabilities; they are not the same article.

Evaluate site feasibility for upcoming cardiovascular protocols at amavitaresearch.com. Bring the inclusion criteria. We will tell you whether the panel and the investigators match before anyone prints a startup checklist.