Improving accessibility drives faster and more efficient patient enrollment and a more diverse trial population.
Clinical trials are vital for the development of effective and trustworthy drugs and treatments, and one of the pillars of their success is the enrollment of an ample, diverse patient body. Swift patient enrollment enables clinical trials to run more smoothly and produce more reliable results, ultimately bringing new treatments to market faster.
However, patient enrollment is proving increasingly challenging. Trials have grown in length and complexity over the years, making it more difficult to recruit a diverse population that's able to commit to the full extent of the trial, travel to medical sites, and meet the relevant requirements. Trial sponsors have been struggling to find a way to make clinical trials more accessible and patient-centric, without compromising on data integrity or pushing costs up.
For a brief period of time, decentralized clinical trials (DCTs) seemed like an ideal solution. But the model had flaws that made it unsustainable in the long run. Today, new technology offers a different alternative that could resolve many problems: satellite trial sites.
DCTs involve conducting most of a clinical trial from a major medical center, using digital technology and home-based healthcare services to replace attendance at clinical trial sites. COVID-19, which made it significantly harder for participants to arrive at any medical center, brought a surge in popularity for DCT and for companies such as Science 37, Medable, and Thread Research, which offered the technology to make it possible.
In many ways, this was a very positive development because it broke from traditional practice, which insisted every aspect of a clinical trial had to take place at the central trial location. However, DCT had many challenges, primarily because it attempted to bypass the medical center. The collapse of Science 37 and its plunge from a valuation of $1 billion in 2021 to $38 million in 2024 emphasizes this fall from grace.
A patient-centric solution is needed, however DCT as a standalone approach isn’t viable without the participation of small and medium medical centers. A hybrid model that includes major medical centers and smaller sites is the future for clinical trials and will truly provide a patient-centric solution. This model can serve as the middle ground between traditional centralized trials that are limited to major medical centers in large cities and fully remote DCT.
Satellite sites are not a new concept in clinical trials, but until now, they haven’t been widely adopted for various reasons, including lack of clinical trial expertise, manpower shortages, and other logistical reasons.
Establishing satellite trial sites at smaller, local medical centers offers a swathe of benefits both for patients and for trial sponsors. It's an approach that was recently suggested in The New England Journal of Medicine by a group of medical professionals who encouraged building inclusive trial infrastructure in underserved communities.
It's far more convenient for patients to reach their local medical center than a centralized trial site that is often far away, especially for patients with limited mobility, severe pain, and those from lower socio-economic backgrounds who rely heavily on public transportation. For example, in many oncology trials, the patient needs to come every two to three weeks to a major medical center, which is often a significant burden that ultimately closes the door for many patients who would otherwise participate in trials.
DCTs developed many creative ways to deliver investigational products to patients at home, but with satellite sites, medical professionals can deliver drugs and treatments more efficiently in the local medical center, while actively tracking patient reactions. Additionally, when treated in a medical center rather than at home, patients tend to feel a greater sense of belonging to the broader study, and to develop stronger trust connections with the team that's supporting them.
For example, the University of Utah is a nationally recognized center for clinical trials, serving as the biggest trial center across several states, but it's not easily accessible for most patients. A more comfortable solution would be for the medical center to create a network of satellite sites in surrounding boroughs and states to expand its reach and open its trials to more patients.
In this model, eligibility screening and an introductory meeting can be held at the central site, but subsequent interactions would take place closer to the patients' homes. Improving accessibility in this way is a core principle of patient-centric care, which in turn, drives faster and more efficient patient enrollment and a more diverse trial population.
Until recently, satellite trial sites weren't practical. Fortunately, technology has moved fast, even in the few years since peak COVID. Today, trial sponsors have access to technologies that make satellite sites a viable and more practical alternative.
Chief among them are improved tools for collecting and transmitting trial data. Advanced monitoring platforms ensure that patients are tracked as effectively as they would be at central sites, and remote feedback platforms such as ePRO, eClinRo, and eCOA streamline patient feedback.
Innovative data management systems can now stream the data collected by professionals in the satellite center’s electronic health record (EHR) directly to the sponsor’s EDC. With this technology, data arrives within hours instead of weeks, and is more accurate than when manual data entry was the only way to transfer patient records. When trial sponsors receive reliable data in near real time, it improves patient oversight and care.
Additionally, trial sponsors can avail themselves of better drug delivery systems, which help guarantee that remote medical centers receive the drugs they need, and that patients are given the treatments that have been properly prepared. New remote training tools also make it easier to train staff at satellite sites in trial protocols, and to verify that they've mastered monitoring and data management processes.
New technologies enable the transition from a site-centric approach to a patient-centric approach in clinical trials, which ultimately increases patient access and improves the clinical trial process for patients, site staff, and sponsors.
DCTs succeeded in breaking through rigid norms and creating space for a new approach to clinical trials. However, the model didn’t deliver a comprehensive solution to the challenges of clinical trials. Now that the technology exists, local medical centers can be used as satellite trial sites to make clinical trials far more accessible, enabling a more diverse trial population, speeding up patient enrollment, and ultimately driving new treatments to market.
About the Author
Iddo Peleg is CEO and cofounder of Yonalink.
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