With the unprecedented increase of innovative clinical trials in oncology comes a new emphasis on broadening access, resulting in trials moving closer to where patients live. These developments make the untapped potential of satellite and affiliate locations an important niche to develop. Their unused capacity and often unrecognized capabilities can help sponsors elevate productivity and increase efficiency, breaking many of the historic misconceptions that have siloed today’s clinical trial architecture.
This blog post, created in collaboration with Roswell Park Comprehensive Cancer Center, outlines the potential of satellite and affiliate sites to foster broader and more agile enrollment initiatives, increase penetration into close-knit or rare markets, and transform patient experiences to give sponsors an advantage in an increasingly competitive clinical trial recruitment environment.
There was a time when modern research equipment and top-performing talent were clustered around large, well-established sites. However, wide-spread urbanization, private funding, and transformative advances in communication technology have elevated the infrastructure and experience of many smaller facilities. Physicians working at these sites may not have the academic name recognition of practitioners at leading academic institutions, but many of them trained at large cancer centers of excellence and are interested in—and capable of—participating in clinical research. Armed with these capabilities, these qualified individuals are often more readily available to accommodate the administrative and clinical efforts associated with supporting a trial, as long as the proper infrastructure exists.
Satellite sites are often overlooked for Phase 1 studies due to potential lab and pharmacy complexities or perceived knowledge gaps. While it remains true that some patients may need to visit larger sites for specialized imaging, biopsies and other more complex testing, satellites can regularly handle many common time- and resource-intensive procedures such as serial ECG/EKG readings, multiple pharmacokinetic samplings, biomarker blood draws, and sample shipments. With fewer studies competing for their attention, satellite sites may be able to dedicate more staff to clinical trials. By following protocols established by the primary clinical trial site, these satellites can generate quality data that is on par with larger research centers, and by intelligently distributing workloads, eager investigators and research coordinators could be empowered to perform what would likely be considered intellectually exciting and engaging work.
Ultimately, the decision to include satellite sites in a trial should be made on a case-by-case basis and informed by a discussion about access to the target patient population as well as the resources, equipment, and time available to dedicate to fulfilling the requirements of the study protocol. Academic networks will be familiar with the capabilities of their satellites and can provide insight on their suitability for inclusion. Our experience shows that satellites are less likely to take on studies they would not be able to deliver and thus are more likely to hit their promised enrollment targets compared to larger institutions.
To streamline the site selection and startup process, sponsors should look for satellite sites that are part of a larger network. In addition to being able to use patient population data to identify sites that are likely to perform well, affiliation with an academic network:
Participation in clinical research enables access to new treatments but can be a challenge for patients due to the burden of trial-related appointments and the need to travel to research sites that may be far from where they live. These challenges are exacerbated for patients with cancer who may be seriously ill. To aid recruitment, ensure compliance, and support retention, sponsors may benefit from carefully considering approaches to making a trial more accessible and attractive for participants. Even the logistics associated with driving to and finding parking in metropolitan areas can be sufficient to discourage participation in a clinical trial. Finding ways to make a study more patient-centric is essential.
Satellite sites can begin to address this need by bringing the trial to the patient, eliminating long-distance travel, and reducing the burden of study participation. At the height of the global pandemic, when COVID-19 resulted in site closures and travel restrictions, sponsors turned to local healthcare providers and mobile research nurses to keep trials moving forward. Maintaining the convenience of closer-to-home studies may encourage participation and accelerate enrollment.
As patients and local physicians become more accustomed to clinical trials, they are seemingly more receptive to study participation, with some proactively seeking opportunities to get involved. Additionally, widespread access to online information is increasing clinical trial awareness, opening the door for satellite sites to further amplify a study’s reach. When evaluating these sites, sponsors should consider the hospital networks with which these sites are associated. Within and among large urban research centers and community hospitals, network physicians often collaborate on important initiatives, broadening the base of potential study participants.
Moreover, satellite sites open studies up to new geographies and demographics, enhancing patient access and increasing representation in groups that have historically shied away from clinical trials. Greater diversity of trial participants fosters more inclusive study data—the importance of which has been emphasized by the FDA, National Cancer Institute, and industry leaders. As study participants should be representative of the patients who will use the investigative products post approval, the FDA believes the shift toward improved diversity in clinical trials is critical to advancing health equity.
The inclusion of satellite sites in a clinical trial can be a competitive differentiator for sponsors, providing an edge in today’s crowded recruitment landscape and making study participation a viable option for a broader, more diverse population.
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Roswell Park Comprehensive Cancer Center has served its community for more than 120 years with care characterized by its compassion, innovation, and effectiveness. Founded in 1898, Roswell Park today remains the only comprehensive cancer center designated by the National Cancer Institute (NCI) in Upstate New York, caring for more than 44,000 patients each year. Roswell Park helps set international standards in cancer care as a member of the National Comprehensive Cancer Network, and consistently earns patient-satisfaction scores that are among the highest in the country. In addition to its main campus on 29 acres near downtown Buffalo, New York, Roswell Park operates two satellite centers and provides oncology services across New York State through the Roswell Park Care Network.