In the ever-evolving and high-stakes world of clinical trials, no two sites are identical. Site-to-site variability in performance is shaped by numerous factors, ranging from institutional experience and staffing levels to infrastructure capabilities and patient population access.
Low enrolment is one of the leading reasons for clinical trial termination[i], making it a key priority during the selection process. To meet enrollment goals, a site must have access to sufficient eligible patients. This is where site selection becomes data-driven, using a combination of geographic and demographic assessments, electronic medical record (EMR) queries, and historical enrollment data to answer three important questions:
- Is there a high enough prevalence of the disease within the site’s geographic reach?
- Does the site have access to these patients within its databases?
- Can the site demonstrate its ability to efficiently and effectively enroll similar patients in previous trials?
But while enrolment potential is front and centre during site selection, it is by no means the only factor to consider. When assessing site feasibility, sponsors must evaluate practical considerations such as staff numbers, staff skillsets, training requirements, physical infrastructure and ability to store IMP, equipment, and competing trials. Trial experience and clinical experience are also at the top of the list, yet these shouldn’t necessarily be conflated with established or high-profile sites.
Are we overlooking “research-naïve” sites?
While traditional industry wisdom might favour sites with a long track record of trial execution, it’s critical not to overlook the potential in emerging and so-called “research-naïve” locations.
“A newer site might just simply be a new address in a database,” says John Kennett, Global Marketing Director at Fortrea, an industry leading contract research organisation (CRO).
Labelling a site as “naïve” is often misleading, he adds. New site businesses do not emerge from a vacuum; they are typically led by experienced professionals operating in new geographies or settings. Embracing these sites can yield long-term advantages, such as increased trial capacity, reduced competition for patients, and enhanced access to underrepresented populations.
Indeed, while established sites may give sponsors a sense of security, over-reliance on saturated, high-volume research centres can have unintended negative effects. Investigator availability may be constrained, and competition for eligible patients can erode recruitment rates. By contrast, diversifying the trial site network to include community-based settings, smaller institutions, and geographically dispersed sites broadens the pool of potential participants and helps trials stay on track. This is particularly important in rare disease research and in studies requiring broader geographic reach to meet recruitment targets and regulatory milestones.
It’s also worth considering how diversifying a trial’s site network could in turn increase the diversity of patients enrolled. For instance, community hospitals may represent a more accessible option for patients, possibly supporting the enrollment of lower-income groups and racial minorities.
A collaborative approach to getting up-and-running
Once a diverse and capable site network has been selected, ensuring each individual site’s readiness requires tailored support from experienced CROs. Fortrea champions a bespoke, collaborative approach to study start-up, one that ensures each trial site is both well-prepared and empowered to deliver. This ranges from workflow optimisation and training to strategic introduction of enabling technologies and timely, streamlined payments.
“Our coordinators help sites get up-and-running from the get-go, making sure they’ve got everything in place and the availability to perform the protocol effectively,” explains Kennett. “The worst thing we can do is give them a lot of work they can’t handle and then they don’t want to talk to us about it, because that becomes a problem.”
He adds: “At Fortrea, we’re flipping that around, making sure we give sites work that they can do because they’re equipped to do so, they’ve seen it coming well in advance, and they know that they can pick up the phone to speak to somebody at any time, ask them questions, and receive support.”
Central to this is the goal of reducing investigator and patient frustration, thereby minimising burnout, dropout, and protocol amendments, all of which impact trial integrity and cost. The benefits of this tailored, collaborative approach are clear: trials that remain on budget, adhere to timelines, and generate statistically viable, high-quality data. But the impact goes deeper. By nurturing the site network and supporting up-and-coming sites, Fortrea is investing in the next generation of clinical researchers and building resilience into the global trial ecosystem.
Through deliberate strategy and meaningful collaborations, Fortrea is setting a new standard in clinical trial site engagement, where every site, whether seasoned or emerging, is given the tools and trust to thrive.
To learn more about addressing site-specific challenges to improve site engagement, please download the whitepaper below.
[i] https://www.clinicaltrialsarena.com/analyst-comment/clinical-trial-sites-brunt-failures/
