Clinical Researcher—April 2022 (Volume 36, Issue 2)
PEER REVIEWED
Esther Mahillo, PhD, MBA
Today, there are more than 15,000 open or planned clinical trials in the United States, approximately 5,500 of which are for oncology therapies. With large cancer centers like MD Anderson and Memorial Sloan Kettering managing an estimated 1,100 and 700 clinical trials, respectively—and with the number of studies expected to expand at a compound annual growth rate of 5.7% from 2021 to 2028—there exists a tremendous opportunity for satellite sites to support the expansion of this $44 billion dollar industry.{1}
Investigator satellite sites are an important and underutilized strategic resource, and some in the industry even see them as the next rising star in clinical research. The term “satellite site,” as it relates to clinical trials, has been used in various contexts throughout the years. For the purposes of this article, the term covers independently operated study sites based within private physician practices, standalone hospitals, and other small, typically community-based, sites which large academic medical centers (AMCs) can turn to for help with certain trials on a case-by-case basis. It does not include sites that are run directly by sponsor organizations or as members of site management organizations, research consortia, or other forms of large research networks.
Due to historic misconceptions about their capabilities, resources, and output, satellite sites are often overlooked in clinical research. Today, however, these sites may be fully equipped with modern infrastructures and feature practitioners trained at prominent cancer centers of excellence who have vast clinical trial experience. The potential of these sites to add value in oncology clinical trials, as discussed further below, is tremendous, in that they often feature well-trained staff who can be dedicated to research projects, have experience with lab sampling, and understand the complexities of handling investigational products (IPs).
When added on an as-needed (temporary) basis to an existing AMC network of sites to contribute to the conduct of complex, multisite trials, satellite sites often already have all the necessary equipment to run such studies, and can quickly come up to speed with the robust compliance protocols and established standard operating procedures (SOPs) necessary for IP transfers from the primary site to the satellite. Some AMCs even make it easier for satellite sites to participate by using centralized institutional review board (IRB) approvals and employing uniform methods for capturing electronic delegation of authority logs. The symbiotic relationship between satellites and the primary site adds a new dimension to clinical trial conduct.
The Advantages of Satellite Sites for Oncology Trials
For people with cancer, satellite involvement can make clinical trial participation more appealing. Patients who seek inclusion in clinical research are likely to have a well-established relationship with their local oncologist, often preferring to stay with their doctor versus being transferred to a new oncologist at a larger research center further from their home. By virtue of their location, satellite sites enable clinical trial participants to stay within more familiar territory, eliminating the need to travel unnecessarily and lowering the barrier to entry for those who cannot accommodate the rigorous demands of study participation—often members of underprivileged groups, the exclusion of which results in skewed population metrics for trials.
Extracting the most benefit from the partnership between satellite and primary sites means sponsors must understand the varying degrees of maturity and centralization across the affiliate networks. These are just some of the considerations that can drive the selection of a satellite network partnership:
Capability: Satellite sites come in all different shapes and sizes. It is crucial to match a study’s protocol requirements with those of the AMC network and satellite sites being considered. Centralized training conducted by a primary academic site, along with oversight of start-up processes, is a common practice to ensure an on-time study start.
Capacity and Patient Match: Satellite sites are likely to have less competition for certain patient groups than large cancer centers. Additionally, by bringing trials out into more suburban areas, the enrollment area can expand to a broader and more diverse population.
Researching these criteria will be challenging for sponsors, but partnering with a qualified primary clinical trial site that has a well-established roster of satellite sites that may be relied on when the need arises eliminates hurdles regarding obtaining information on where suitable patients are located and where they are in their treatment journey.
Other Keys to Success with Satellite Sites
The primary academic site understands each of its satellite sites’ capabilities and can identify those that make sense for a specific trial.
Some sites excel at investigational trial work, others at biospecimen collections. AMCs with satellite site networks (Roswell Park, for example) have intimate knowledge of their collective sites’ strengths and patient populations. This enables sponsors to find the right investigators for their trial and generate higher quality data from the harmonized processes across this network.
Many organizations have invested heavily in SOPs, data platforms, and administrative services to create tremendous efficiencies and bring the capabilities of large sites to satellite locations. This helps them to:
- Ensure proper training, oversight, and infrastructure, potentially eliminating the need for site qualification visits at satellite sites.
- Provide contractual harmonization for most legal language and budgetary items—only small nuances reflect individual site capabilities and needs.
- Enable centralized, streamlined start-up activities, combined training activities, and potentially minimized delays in IRB approvals and navigation through other administrative red tape.
Many satellite site networks have uniform systems that centralize information on patient locations and diagnoses.
Targeting specific patient populations can be a daunting challenge. With standardized electronic medical record (EMR) systems, data collection can be streamlined to create more uniform treatment pathways and drive more consistent patient tracking and care.
Centralized and uniformed access to patient information simplifies the identification of potential trial participants and provides other value-added benefits to a study, including:
- SOPs and shared trial management platforms can drive consistency across a study to establish a strong baseline.
- Data from the EMR is uniform and always accessible, which eliminates the need to establish baseline using expensive claims data.
Satellite locations make a local presence possible, bringing science closer to patients.
Study participation will always pose some degree of burden, but with the COVID-19 pandemic, the paradigm shifted. The influx of patients to large academic sites made local community centers step up to handle the overflow of trial work. Despite this unplanned involvement, studies continued to run successfully, demonstrating the abilities of select sites to support oncology clinical trials and marking an important step forward toward more patient-friendly study practices.
Finding other ways to minimize the burden of participation on patients will be key to supporting them in their time of need, as well as for making studies more attractive—an important consideration for patient enrollment and an on-time study start. The challenges in this area include:
- The difficulties of travel—driving to metropolitan areas, parking, and time off work—make enrollment burdensome, discouraging people from participating in a trial. Having a trial accessible at a satellite location greatly reduce the hassle of commuting.
- Patient comfort is an important factor to reduce anxiety. This can include wanting to stay with their regular physician whom they trust (potentially avoiding loss of knowledge regarding the patient’s condition).
- Improving representation is an ongoing challenge; however, suburban sites may be more accessible to certain groups who do not have the ability to take extended time off from work or the means to travel long distances.
The inclusion of satellite sites in a clinical trial can be a competitive differentiator for sponsors.
Growing competition and other enrollment challenges amplify the importance of easier trial participation experiences. Patient-centric considerations, together with network-enabled patient insights, make selecting satellite sites a far more digestible option.
By successfully pairing the right sites with the right studies, sponsors can improve the breadth and quality of data, drive enrollment more representative of real-world populations, and create better experiences by bringing the science closer to the patient. As the industry continues its shift toward decentralization, satellite sites will continue to play a key role in realization of patient-centric clinical trials.
As the numbers of trials continue to grow, sponsors who partner with academic sites with mature site networks to implement decentralized clinical trial strategies will benefit from the added capacity of highly skilled and motivated staff and faster enrollment from a broader patient reach, while continuing to maintain data quality. However, the most important driver of satellite site involvement lies beyond the dollars and cents.
Conclusion
Cancer can strike any person at any time and the impact spreads extends far beyond the patient, affecting families, caregivers, friends, neighbors, and coworkers. Today’s reality is that many clinical trials are not accessible to the people who need them the most due to the high demands of study participation. This does not have to be the case. As various AMCs have already demonstrated, by implementing standardized processes and procedures, with centralized training and oversight by the primary site, they are able to bring the trials to the ones who matter the most—the patients.
Reference
- Grand View Research. 2021. Clinical Trials Market Size, Share, and Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design (Interventional, Observational, Expanded Access), by Indication, by Region, and Segment Forecasts 2021–2028.
Esther Mahillo, PhD, MBA, is Vice President of Operational Strategy and Feasibility at Precision for Medicine in Madrid, Spain. She has more than 25 years of experience in the clinical research arena (22 of them in global oncology trials), and is a master’s program professor at three different universities. In 2015, she was awarded the first prize of the Spanish Society of Medical Oncology contest for her work on the promotion of clinical research.
