Author: MRN
Over the last 20 years we have seen the clinical trial landscape simultaneously shift into embracing new technologies and methods for study design, management, and recruitment, while simultaneously clinging onto old concepts of what a clinical trial should look like and where clinical trials should take place.
COVID-19 then forced a lot of change very quickly – and virtual and remote clinical trials suddenly became less of a novelty, only to be used for simper trials, and more of a necessity. Yet as the world started to work to get back to what was considered “normal”, we saw another shift in the industry – one where there is not just the creation of fully decentralized or remote virtual trials, but rather a hybrid: with some study visits carried out through solutions such as in-home visits (like Home Trial Support) or tele-visits.
While both of these approaches allow for greater flexibility, and greater reach, they both still require the patient to travel to a trial site for a number of visits – which will vary depending on the trial and what is stipulated by the Sponsor and Principal Investigator.
This means that while the burden of trial participation is eased, it is not fully alleviated. To address this it is time to move away from thinking that trials still need traditional sites in order to conduct complex clinical trials. This doesn’t mean moving away from sites altogether. Quite the opposite – it means bringing more sites into different communities, globally.
Community Sites In Clinical Trials
The benefits of working with community-based sites are boundless. Not only do many of these sites have established relationships with patients and community physicians and pharmacists alike, but they are often more representative of the population they are treating – and are members of the community they provide care to. Further, these sites are in more convenient locations – closer to homes, schools and workplaces, which makes it that much easier to get to and from for appointments and check-ups.
This can instantly give a lift to both trial recruitment and retention (one of the top three biggest challenges trials continue to face1). Sites are now easier to visit, and established relationships eases the pressure on trial recruitment.
Yet again, sites alone cannot and do not fully ease and eliminate trial participation burden on patients. It is important to remember that for some, physical movement, even just a short trip, can be a mammoth task – whether it is due to mobility or pain or both. Further, with those suffering from neuro-degenerative diagnosis, leaving their safe space to go somewhere unfamiliar can be too overwhelming. There are also those who may be quite severely immunocompromised and every visit to a public healthcare environment is a risk. We also have to consider work, family and caring obligations that can still make a clinic visit, no matter how close, feel like a lifetime.
Patient-centered, Community-focused Site Networks Are The New “Remote/Virtual”
The solution is – there is no one single solution. Just as the new innovative, and novel therapies require a tailored and drug-specific approach to their development, so does the design of the clinical trial that will ensure its efficacy and safety. Essentially, there is no one-size fits all…but there is powerful combination that can be utilized to fit and adapt to the needs of each trial, each site and each patient.
Site networks that are working with community and trial-naïve sites are creating that community-based groundwork that allows for greater reach and increased recruitment and retention. Taking it beyond community-based to community-focused is the next step: a site network that works with, supports and develops community and trial naïve sites and amplifies their impact – expanding reach into communities that may never have had access to a clinical trial site in their own backyard.
Taking this community focused approach and then combining it with a patient-centered solution, such as in-home visits through Home Trial Support paired with a telehealth option, creates the same look and feel of a remote or virtual trial – creating flexible options for patients that allow them to opt to have trial visits conducted in their home or other appropriate location (specific number of visits that can be conducted in-home would be determined by the Sponsor and Principal Investigator and dependent on patient preference), with any required site visits being more infrequent and as short as possible.
The results extend beyond just providing patients with flexibility and proximity to healthcare. They are also creating sustainability and increasing capability of community-based and trial naïve sites.
Further, for sponsors, the long-term financial burden of enrollment targets and deadlines being missed is alleviated and the real-world generalizability of the data gathered helps secure the approvals of much needed treatment and therapies.
It takes a site network that is driven by a team that truly believe that progress, and out-the-box thinking, is the best way to serve global patient populations and an industry that is trying to make the world a healthier place to be.
MRN’s global Site Network is working with sites, patients and sponsors to achieve this. Learn how they can help your trial or site to reach more patients here.
References:
- WCG. 2024 Clinical Research Site Challenges Report. https://www.wcgclinical.com/wp-content/uploads/2024/10/WCG_2024_Clinical_Research_Site_Challenges_Report.pdf. Last accessed June 2025.