By Dr Graham Wylie – Chairman and CEO, the Medical Research Network
Around a decade ago, I read a piece of research, likely in the Harvard Business Review, that stuck with me. It noted that you could build a McDonald’s right next to an existing one, and both locations would attract the same number of customers and make equal financial returns. The market was nowhere near saturation.
I also once spent a fascinating afternoon watching a new McDonald’s go up outside my office window. Over a month, the old pub opposite was demolished. Then, in a single afternoon, three flatbed lorries arrived carrying prefabricated modules:
- Lorry 1: Kitchen fully installed.
- Lorry 2: Seats, tables, and a fully fitted restroom.
- Lorry 3: The building front, complete with the golden arches.
Within an hour or so, the building was assembled. A week later, it opened.
Prepackaged and Side-by-Side
Creating a clinical trial site operates on a remarkably similar model. The core trial components are standardised and prepackaged. Everyone knows the standards and deliverables, requiring minimal friction to connect the site with a pharmaceutical sponsor. And once established, it can recruit just as many patients as the site right down the road.
Why don’t neighbouring sites cannibalise each other’s patients?
Because trial sites draw small pools of registered patients from massive metropolitan areas. Most specialists carry a load of 1,000 to 1,500 patients out of a general population of 75,000 to 100,000. Because individual specialist scale is limited, major cities host dozens of them – London has roughly 110 rheumatologists; Chicago has over 180 – all drawing from geographically overlapping populations.
Outside major cities, specialists aggregate to share services, serving separate patient pools under unified umbrella organisations.
The Industry Bottleneck
This structure creates several distinct industry challenges:
- You cannot build enough sites to saturate the patient population – it is simply too expensive.
- Sites sit side-by-side without competing, yet experienced sites find it nearly impossible to grow because patients must be referred in rather than “assimilated”.
- Many patients are ignored entirely.
That last point is critical. We repeatedly choose the same well-funded, highly experienced sites. But not all patients have access to – or interest in – these mainstream, comfortable sites.
Meanwhile, the pool of investigators isn’t growing to compensate. By some estimates, two-thirds of Principal Investigators (PIs) leave clinical research after a single study. Just maintaining current investigator numbers is a struggle, let alone expanding them.
Systemic Barriers Holding Patients Back
If the medical system itself resists crossing referral and geographic barriers, patients taking control of their own care destiny will be the true catalyst for change. However, traditional regulations and processes continually reinforce the status quo:
- Source Data Verification (SDV): The requirement to transfer physical patient notes embeds referral barriers directly into pharma operations. Notes transfers are notoriously slow, and original physicians have no incentive to “give up” a patient. Patients literally wait, and sometimes suffer, while sites demand original records for diagnoses that could easily be re-verified on-site.
- Rigid Site Licensing: Forcing specialists to list a single physical address on trial forms restricts access to only the patients living near that specific clinic. It also limits trial visits to specific days of the week and creates massive administrative overhead.
- Over-engineered Staffing Requirements: Insisting on highly experienced research nurses when basic nursing skills are all that the protocol requires sets an unnecessary barrier to entry.
- State-by-State Telemedicine Laws: In the U.S., a physician must generally hold a license in the state where the patient is physically located during a virtual visit. A rule intended to protect local care standards ends up rebuilding geographic walls inside the exact technology designed to break them down.
Signs of Movement
There are reasons for optimism. Regulatory bodies are beginning to push back against these legacy constraints. For instance, the FDA’s guidance on enhancing clinical trial participation explicitly asks sponsors to recruit patients across broader geographies, co-morbidities, and circumstances – not just demographics.
We don’t have to wait for the entire global system to rewrite its rules. We can extend the reach of existing sites through:
- Site Amplification: Extending site reach directly into patient homes via home visits, tele-health, and community-based delivery. Patients can participate without changing physicians or transferring records.
- Integrated Site Platforms: Setting up new access points that use decentralised tools to fill geographic gaps without disrupting traditional sites.
- Process Un-sticking: Encouraging sponsors and CROs to audit their protocols and remove unintentional operational barriers.
So, why does McDonald’s do it?
McDonald’s can build side-by-side locations because every restaurant generates a profit.
In clinical trials, however, we operate within a fixed patient total. The perceived cost of adding sites feels high compared to the risk of trial delays and as an industry, we rarely admit we’ll be delayed. After all, we selected the best-equipped hospitals with the most experienced teams… right?
