Author: MRN
In our collective pursuit of more inclusive, representative clinical trials, one critical question continues to resurface:
Are we truly tapping into communities that reflect the real-world diversity of patients?
Too often, the answer is still no.
Despite years of conversation around inclusivity, the clinical research industry remains largely tethered to the same pool of experienced sites. Meanwhile, community-based and trial-naïve sites – those embedded in underserved and underrepresented populations – are routinely passed over. Not because they lack potential, but because they lack support.
The Problem: We Default to the Familiar
Sponsors and CROs tend to select experienced sites with known performance metrics and existing research infrastructure. It’s an understandable instinct, but one that creates a self-fulfilling cycle. Trial-naïve and low-resourced community sites are viewed as high-risk, with no comparable metrics to rely on, or potentially too slow as they don’t have enough support, and therefore never get the opportunity to prove otherwise.
The result? Continued underrepresentation of diverse patient populations, limited geographical reach, and missed opportunities for meaningful inclusion.
But what if “trial-naïve” didn’t mean incapable? What if it just meant untapped?
The Solution: Empowerment Through Support
We believe the answer lies in targeted, resource-driven site enablement. Through services like Site Professional Support (SPS) and Home Trial Support (HTS), we’ve seen firsthand how trial-naïve sites can be high-performing contributors when equipped with the right tools.
Let’s look at a recent example.
A late-phase Rheumatoid Arthritis study needed wide UK coverage, which would have to include sites with no previous trial experience to achieve this. Traditionally, these sites wouldn’t have made the cut but, with MRN’s SPS model, 14 trial-naïve sites were not just selected and then activated – they thrived.
The Results: Trial-Naïve Doesn’t Mean Underperformance
While the 20 experienced sites in the study recruited faster initially (as expected), MRN-supported trial-naïve sites recruited more patients per site (3.7 vs. 3.1) overall. Even more compelling, these sites sustained their momentum over time – continuing to enroll patients while others plateaued.
By placing experienced research nurses and coordinators directly at these under-resourced sites, MRN enabled them to deliver complex visits. These included monthly 2-hour infusions, additional assessments, and quality-of-life measures, all within dedicated infusion suites. The result was greater recruitment efficiency and, more importantly, long-term research capacity.
This isn’t just a win for a single study. It’s an investment in the broader research ecosystem.
The Bigger Picture: Expanding Access, Strengthening Infrastructure
When trial-naïve sites are supported, we don’t just increase site diversity – we expand the geographical and demographic footprint of clinical trials. We create access points for patients who might never have been reached by traditional models.
This is particularly impactful when combined with Home Trial Support. By bringing trials into the patient’s home HTS removes participation barriers that include, but are most certainly not limited to, travel time and logistics, taking time off work, and any mobility issues the patient may face. HTS can also offer a host of hidden healthcare benefits (you can read about these here) that can actually make trial participation a better option for the patient. It’s not just about convenience. It’s about accessibility.
Together, SPS and HTS bring trials to where the patients are, rather than placing the burden on the patients to fit into the mold of traditional trial designs and, by extension, traditional sites. This is how we begin to shift the landscape – by making trials genuinely inclusive, not just through intention, but through execution.
The Opportunity Ahead
There is a persistent diversity problem in clinical research. But there is also opportunity.
If we want to move the needle on inclusion, we can’t keep defaulting to the same trusted sites and expecting new outcomes. We need to invest both in where patients are, and in the sites that will reach them.
The results of the arthritis study show that with the right backing, trial-naïve sites do outperform expectations and bring new patients into the clinical research fold – patients who reflect the realities of our healthcare systems and disease burdens.
Supporting trial-naïve and community-based sites isn’t a nice-to-have, it’s essential. Every patient deserves the opportunity to participate in research and every community deserves representation in the development of new medicines and therapies.
Learn more about how MRN is able to help transform access to clinical trials with Home Trial Support and our global Site Network.