Matt dives into a specific healthcare topic to help those in the industry, and those outside of it, better understand the market drivers causing today’s healthcare challenges.

Eleven of twelve sites enrolled almost nobody. The clinical operations team already had the answer teed up before anyone finished asking the question: the eligibility criteria are too tight; loosen them. It is the reflex fix. It is also the wrong one. Loosening the criteria would have compromised the science and salvaged nothing, because the criteria were never the barrier. Nobody had asked a single patient why they were saying no.

I have sat in the room when an enrollment curve goes flat, and I can tell you what happens next. The conversation turns to protocol amendments, site activation, and recruitment vendors. It almost never turns to the patient, because by the time enrollment stalls, the patient has been reclassified from a person with a fear into a number that will not move. The industry spends billions engineering trial design and treats the patient as the last stakeholder to consult. Then it acts surprised when the curve flatlines. We do not have a recruitment problem. We have a listening problem, and this month I can finally put a price on it.

Here is the case, start to finish, from a Phase 2b program written up in Applied Clinical Trials. Eleven of twelve sites were enrolling few or no patients. The team went to the investigators first, as everyone does, and the investigators produced no consistent explanation. Sit with that, because it is the real finding. The people closest to the patient, the ones with the white coats and the relationships, could not name the barrier. That is not a knock on the investigators. It is proof that proximity is not the same as insight.

So, the team did the one thing nobody had done. They surveyed patients who matched the inclusion criteria and asked them directly. The obstacle surfaced immediately. Patients were afraid of a widely feared adverse effect tied to the active comparator arm. A concern real enough to kill enrollment across eleven sites, and not one investigator had raised it.

The team did not loosen the criteria. They did not touch the comparator. They kept the science intact and built patient education plus site training that covered the adverse effect's actual incidence and its reversibility. Enrollment completed in roughly three months.

A survey. Three extra months. That is the entire intervention.

Now widen the lens, because the timing matters. This is the same stretch where 340B purchases crossed $100 billion, up 22.8 percent year over year (STAT, July 14), and HCA raised its exchange coverage loss guidance to between $1 and $1.2 billion (Modern Healthcare, July 15). Access is contracting from every direction at once. Against that backdrop, the one lever in this story that reliably worked cost the price of a survey. When every expensive fix is failing, the cheap one that works should get your full attention.

Name the structure, not the vibe. This was not one person dropping a ball. It was an org chart doing exactly what it was built to do.

Clinical operations owns enrollment. Medical affairs owns the investigators. Advocacy owns the patient relationships and sits three floors and two budget lines away from the protocol. In that arrangement, the only function with a direct line to patient fear has no authority over the document that manufactures it. When enrollment stalled, the escalation ran straight to clinical ops, and clinical ops proposed loosening criteria, because loosening criteria is the only lever clinical ops holds. Nobody routed the problem to the team that actually talks to patients, because that team is filed under external relations and funded as a communications line item.

That last part is the whole game. When advocacy is funded under corporate communications instead of under R&D or commercial, you have structurally guaranteed that it gets consulted after the protocol locks. You have defined the one group that knew the answer as a group whose job starts too late to give it. The failure was baked in at budget time, months before a single site went dark.

This is the exact gap the ELAVAY BIOADVOCATE Benchmark exists to measure. ELAVAY scores how patient advocacy organizations actually evaluate the pharma and biotech companies they partner with, rating trust, responsiveness, and commitment to patient outcomes from the advocacy community itself rather than from company self-reports. The distance between how a company rates its own patient-centricity and how the advocacy community rates it is usually the distance between a slide and a survey.

Three years of ELAVAY data show the same thing the case study does: the companies whose scores climb do it through real investment in the advocacy function, not through a better press release. Sanofi is the clean example. From 2024 to 2025 it moved from fifth to fourth overall, lifting its average advocacy rating from 5.23 to 5.79 and its commitment-to-helping-patients score from 5.76 to 6.13, and it did that even as its response rate fell from 29.5 percent to 13.45 percent. That is not a company that got luckier. It is a company that put resources into the function and got rated for it by the advocacy community. Over the same window, former front-runners who coasted slid down the table.

The organizations that would have run the patient survey in month one are the ones that already wire advocacy into the work. The ones that treat it as an audience to broadcast to are the ones that call the survey a nice-to-have and skip it. Responsiveness is not a personality trait. It is a wiring diagram, and ELAVAY has three years of it.

The organizations that get this right do three concrete things, and none of them are expensive.

They put advocacy in the protocol review before the document locks, not in the launch plan after it. They fund advocacy against a P&L line tied to an outcome, so the function survives budget season on evidence instead of goodwill. And they treat advocacy organizations as a research instrument rather than an audience, which means when enrollment slows they call the advocacy group first, because the advocacy group already knows what patients are afraid of.

The team in this case study eventually did the top-tier behavior. They asked the patient. They just did it nine months late, after burning eleven sites to learn a lesson a single survey would have taught them at the start.

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If you cannot answer that today, you do not have a patient-centric program. You have a patient-centric slide.

If you want to know how the advocacy community actually rates your organization on exactly this kind of responsiveness, the 2026 ELAVAY report is now available and you can see how your organization performed now! Reach me directly at [email protected].

And if you want to know whether your own advocacy function has the internal influence to get into that protocol review in the first place, take the Advocacy Influence Diagnostic at aid.elavay.com/survey. It is free, anonymous, and takes five minutes. Five minutes now, or eleven dead sites later. Your call.