Primary Care Research Alliance ‘Flips the Script’ on Site Feasibility

By Deborah Borfitz 

August 11, 2026 | In the U.K., adversity has brought together 180 clinical trial sites—mostly GP (general practitioner) practices but also community health trusts, hospices, and home care providers—to realize that they have more to gain as collaborators than competitors. The mindset shift prompted the formation of the Primary Care Research Alliance (PCRA), which in the space of 18 months has grown from a core group of 12 practices with 250,000 patients to a network representing 8.5 million and counting, according to CEO Daphne Hazell, a longtime GP and wound care expert in the country.  

The alliance has effectively “flipped the script” in UK clinical research because sites, rather than sponsors and CROs, own the feasibility process and police its own claims about patient population availability and capabilities of member sites, she says. It takes a “digital first” approach to “win the studies and win the trust” of clinical research associates (CRAs). 

Hazell will be presenting the unique feasibility model at the upcoming SCOPE Europe event in Barcelona in October. The approach uses simple AI tools to validate recruitment plans, capacity, demographics, performance history, and operational readiness before human review begins.  

Digital accommodations include feasibility counts for multiple sites, based largely on coded GP electronic health records, as well as their historical recruitment rates, says Hazell. The information is visible on the sponsor workspace of the PCRA Portal, together with practice profiles, team expertise, patient population size, geographic spread, and diverse community reach. 

“When CROs and sponsors are looking at the numbers, they’re not having to discount it by 50% for optimism,” Hazell notes. “They can trust the numbers, and they can also trust that if there is a recruitment issue at one site, we have another site ready to go. We always have a backup site for every study, so ... they can trust the [estimated] recruitment timeline is going to happen.” 

Coordinating studies across multiple sites results in a lot of shared learning and resources, she adds. A site struggling to recruit will talk to one who has been highly successful, for instance, or if someone’s fridge breaks, another member will lend them theirs. They can also share pre-screening teams or employ centralized on-call systems available for emergency unblinding. 

“A handful of sites have research vans that go out to patients’ homes, so they can be shared between the sites,” Hazell continues. “This sort of collaborative ethos means that everyone succeeds.” 

Another unique aspect of PCRA is that member sites rent whatever they might need to conduct studies—be they research kits, centrifuges, or -80°C freezers, she says. The alliance contracts with a local company that delivers the supplies and gets a special volume-discounted price. The equipment-sharing model aims to reduce infrastructure barriers that might otherwise prevent practices from participating in research. 

The PCRA now plans to open as a site network in the United States this fall, reveals Hazell, “offering sponsors access to multiple community sites in a single front door.” 

Catalyst for Change  

The PCRA was initiated to increase the flow of clinical research studies into general practice, which came to a near standstill when the COVID pandemic ended, marked by a 25% drop in patient recruitment for industry-sponsored clinical trials, says Hazell. GPs relied on the income from commercial research to fund their other patient activities. 

The U.K. government stepped in with up to one million pounds of funding for each of 14 large primary care research centers to boost their capacity in conducting large phase 3 and vaccine trials, which has increased the volume of studies now running, she continues. The PCRA is supporting capacity and flow of studies in many of the other commercially active U.K. sites that did not receive this funding, specifically for real world evidence studies. 

The study that united the members was not a clinical trial, but an educational intervention study focused on improving the diagnosis of alpha-1 antitrypsin deficiency among primary care physicians. Treatment for the common, serious genetic condition is an active and expanding area of research.  

Over the past year, PCRA has been involved in about a dozen research projects that have included wound care and fatty liver disease studies as well as medical device and healthy volunteer studies. “Before that, we were just an informal network of doctors passing work between us,” says Hazell. 

The projects include small pharma and medical device studies, five of them being regulated clinical trials, she shares. “Some sponsors prefer sites with limited competing study activity, creating opportunities for practices that focus on a small number of trials at any one time ... [and] we tend to fit that niche.” Most alliance members are conducting just one trial at a time, with some of the bigger sites running no more than three simultaneously. 

Sites operate collaboratively, if independently, within the alliance, reports Hazell. If one practice is offered a study but is too busy to take it on, another will be recommended to meet that need. The central team for the alliance, which she leads, knows what is going on with the sites and can therefore appropriately “slot everything in” on a national scale. “In many ways, [PCRA] is like a consultancy that finds sponsors the right sites” while also being a “collaborative national voice” for those practices.

The central team serves as the contact point for both sponsors and sites, maintains control over who gets what study to ensure fairness, and makes the introductions, she says. The practices then take over, with Hazell jumping back in only to sort out any miscommunications that may occur.  

Site-picking 

Much of the communication between sites happens organically, given that in medicine “there’s one degree of separation between everybody,” Hazell says. “A lot of us are friends.” Additionally, there are WhatsApp groups for admin issues and general chat, and of course the PCRA portal. Any work that comes in is posted on the portal for sites to see. Information sites post about themselves is visible to the central team, says Hazell, and any over-promising about patient recruitment numbers, speed, or capabilities will be challenged. 

Typically, one or two sites are the obvious front runners for any study, she says, based on recruitment potential. “Often, it’s geography as well. If there are CRAs nearby, it’s just much easier for everyone, especially on a quick startup.” When geography is a deciding factor, CRAs might go visit a couple of nearby sites. “Often they say they’re going to visit two and pick one, and they end up visiting two and picking two,” says Hazell.  

AI Adoption 

A central admin is “driving AI adoption to keep the alliance lean,” she notes. “The more we can utilize AI, the less spend has to go into manpower and the less cost we have to pass through to sponsors and the more work we can do with the money.” 

An AI tool for writing and structuring standard operating procedures for studies is available for all member sites to use for their first drafts, reducing the time it takes to produce “fantastic SOPs for every eventuality” from eight to 10 hours down to about two, Hazell cites as an example.   

The PCRA also uses an AI pricing tool to make quick work of estimating how much a study is going to cost a site to run, eliminating much of the guesswork, she adds. Pricing is based on the beloved, if incredibly complex, standard costing tool used in the U.K. known as National Contract Value Review (NCVR). 

Almost all GP sites, as well as sponsors and CROs, are now using the non-negotiable NCVR rates simply because it makes their lives easier, says Hazell. “There’s no debate; it just costs what it costs.” The approach also stops the escalation of costs; sites can neither ask for more money nor under-request for needed resources and get into financial difficulties. 

Case Studies 

For one ongoing cardiology device study where PCRA was asked to add a site to replace one that had unexpectedly withdrawn, the alliance recently took just two weeks to move from first contact to contract signed with first patient in expected in the next two weeks. The sponsor already had the necessary approvals from the Medicines and Healthcare products Regulatory Agency, so it was a quick-switch scenario for a niche need, says Hazell. 

The sponsor subsequently requested and chose two more sites for the study, she adds. PCRA put out the request to 12 sites, and some of those responding with their feasibility information indicated they were ready to start within the week.  

It’s standard practice in the U.K. for patients to be recruited with the aid of participant identification centers, or PICs, which are outside sites that refer patients for studies they are not conducting themselves, says Hazell. Suitable patients are found from a search of clinical records and contacted to assess their interest. A single practice needing to enroll 30 patients might use 10 PICs, giving it a pool of 300,000 to meet that target, she offers as an example.  

Perhaps the alliance’s biggest accomplishment to date was for a trial of Aurase Wound Gel being developed by SolasCure, she says. PCRA successfully identified and activated an established wound care provider and transformed it into a fully functioning wound clinical trial center capable of recruiting complex chronic wound patients across a large regional network that provided access to 2 million people. 

Initial introduction to contract completion, as well as site selection to site initiation visit, each took only three months, and the site moved from activation to first patient first visit in just eight weeks—a timeline many sponsors would consider exceptional in a new site set-up, Hazell notes. The site team was supported to establish a regional recruitment infrastructure to significantly expanded the study's reach, resulting in a network comprised of one primary research site, two satellite practice sites, eight NHS wound-care referral hubs, and 13 integrated regional referral touchpoints. A hybrid model was employed, enabling patients to participate through traditional clinic appointments or home nursing visits. 

During the study, 250 patients were screened, 43 progressed beyond initial screening, 20 were enrolled, and 14 were randomized, she reports. While the strict eligibility criteria resulted in a high exclusion rate, PCRA's referral network helped the site randomize 46% of the recruitment target. Of the 14 who entered the study, 12 completed participation (85.7% retention rate). 

Hazell says her long-term ambition for PCRA is that it be an “additional resource” for sponsors and CROs, with the network functioning more as a collaborative learning community. She hopes to raise “passion and enthusiasm for delivering research in primary care knowing how much can be delivered so quickly and to a high quality in [that setting ... rather than] necessarily needing to be in hospitals.”                                         

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