Integrating Technology With Expert Oversight Can Simplify Clinical Trial Enrollment

As cancer care increasingly relies on biomarker-directed treatments, implementing technology that notifies providers of actionable test results is crucial for successful clinical trial matching. Optimal results often hinge on the ability to identify and enroll patients in the appropriate trial as soon as possible. However, the process of matching patients to trials based on their molecular profiles and alerting clinicians is often challenging and time-consuming.

Any initiative that increases the efficiency, accuracy, and timeliness of the complicated trial enrollment process represents a giant step toward advancing targeted therapies and other treatments in the real world. Sarah Cannon Research Institute (SCRI), in collaboration with McKesson and The US Oncology Network (The Network), has launched Central Screening, an innovative new solution to tackle the many challenges involved in trial enrollment. Analyzing some of the obstacles inhibiting this process, as well as SCRI’s unique solutions, may help practices better match patients to the right trials in a shorter time.

Empowering Clinical Trials in Community Oncology

Recognizing the importance of simplifying and streamlining the complicated clinical trial enrollment process, SCRI created Central Screening to drive trial enrollment, which they piloted through a partnership with The Network and McKesson. Designed to reduce the administrative burden associated with identifying potential clinical trial candidates in studies, Central Screening can increase the likelihood that patients will participate in a trial once they are matched based on a trial’s unique criteria.

Rather than being specific to any one site, Central Screening is a centralized resource offered to practices across The Network. Consisting of research nurses and clinical trial coordinators, this team of highly skilled professionals all have experience screening and enrolling patients in trials at research sites. Consequently, they are very familiar with this complicated process.

Integrating Technology With Expertise

Central Screening utilizes McKesson’s robust precision medicine software platform, Genospace, to integrate patient clinical and genomic data. Those data are then matched against the inclusion and exclusion criteria for clinical trial protocols to create a list of matched patients. To validate the fidelity of a potential match, the Central Screening team then engages its scientists to conduct a thorough review of the patient’s chart, carefully examining it to ensure the patient is indeed eligible for the study.

If all elements align properly and the patient qualifies for a trial, the Central Screening team determines when the treating oncologist will meet with the patient. When an appointment is near, they create an alert message specific to that patient and the matched study and send it to the entire care team at the site, including the treating oncologist, the study’s principal investigator, and other site-level research team members. The timing of the alert closely coincides with the patient’s next visit, so the trial is top of mind for the oncologist during the appointment. The message specifically refers to test results that may show signs of progression and the patient’s potential eligibility for a particular trial. An overview of the study design, the drug mechanism of action, and a contact name is included so that this vital information is readily available.

Genospace is currently working to integrate an alerting system into the electronic health record so the care team has a seamless experience with notifications occurring within their normal activities.

Challenges to Overcome

In a typical oncology practice, several obstacles can hamper clinical trial enrollment.For instance, tasks required to match a patient to a trial and notify the care team are not incorporated into the standard workflow within most electronic health record systems nationwide. Data must be integrated from disparate sources, disrupting workflows and increasing the likelihood of missing potentially eligible patients.

The complexity of standard-of-care treatments also presents a barrier for oncologists trying to add trials into the treatment mix. Therapies are increasingly complex, making it challenging for oncologists to stay up to date with new treatments and trial opportunities. When trying to find an appropriate clinical trial through traditional clinical trial search methods (eg, the list generated from commercial next-generation sequencing vendors), an oncologist may receive a list of several clinical trials to choose from with no guidance on which trials are currently enrolling, have available slots, or are most appropriate for their patients. In our experience, it can be overwhelming to investigate alternatives, causing some to move forward with traditional therapies. Trials have also grown more complex, now targeting narrower patient populations and requiring the collection of significantly more data points than in the past.

Practices with multiple clinic locations face additional challenges when patients are treated at clinic locations that do not conduct research. Patients must transition their care to another location to participate, but communicating across the clinic locations and care teams can be difficult due to operational and logistical barriers.

Finally, trial design can be a major obstacle to participation, as some trials for patients with newly diagnosed cancer prohibit any standard treatment before patients are put on a study. Waiting several weeks for screening and test results can generate anxiety in both patients and oncologists. Clinical workflows following value-based pathways favor standard-of-care therapies, where order placement and insurance approval require about a week compared with trial screening times of 2 to 4 weeks. This often results in the oncologist moving ahead with traditional treatment, which may prevent the patient from participating in trials later.

Real-World Experiences

Practices across The Network are utilizing Central Screening and Genospace’s powerful technologies in various ways. Some practices have their own nurses prescreen certain studies each month to identify potential matches or patients who need to be monitored for a possible trial, or they may have individuals screen all scheduled patients on a daily or weekly basis. Once identified, the patients are marked in Genospace’s web portal, which efficiently tracks them over time.

Many practices work with the Central Screening team to screen new patients before their first visit. The Central Screening team assesses patients for systemic therapy trials available through SCRI, which has been very helpful in getting patients on first-line trials. They also help with established patients who might be experiencing disease progression by constantly monitoring patients on certain studies and suggesting other trial options should the patient’s condition change. The team can also provide just-in-time matches for targeted therapy studies involving rare patient subgroups, quickly identifying eligible patients and streamlining enrollment.

Another unique service the Central Screening team offers is peer-to-peer communication between SCRI’s physician disease experts and the treating oncologist. Keeping up with many different advancements across numerous tumor states and treatments can be challenging, so many oncologists appreciate having this connection to a subspecialist for guidance.Being able to rapidly connect to these experts enables oncologists to feel more confident about treatment decisions and gain a better understanding of the therapies in the potential trial matches, and it helps to ensure that patients are receiving optimal care.

Built for Accuracy, Efficiency, and Timeliness

Many obstacles inhibit clinical trial enrollment in community oncology, and it takes considerable investment and commitment to identify these problems and develop creative solutions. Central Screening represents an innovative approach to overcoming barriers that hinder trial enrollment across The Network. It unites the best of both worlds—advanced technologies andexpert human oversight. Although technology-based solutions can incrementally enhance the identification of potential clinical trial participants, their effectiveness is maximized when paired with the Central Screening team’s substantial human expertise, which comprises expert clinical research nurses and coordinators, MDs, and PhD scientists. This comprehensive approach ensures accuracy and provides oncologists with confidence that identified patients are highly suitable candidates for studies.

By making it easier to connect the patient to the trial, Central Screening helps make the entire matching and enrollment process more streamlined, efficient, and timely. Critical information is delivered to care teams in a clear, actionable format, reducing the burden at the site and accelerating the enrollment process.

As cancer care continues to evolve and become more complex, Central Screening also continues to adapt and refine processes to best support physicians and their patients. However, thanks to this initiative, more patients across The Network have access to promising trials while the knowledge base of how to care for patients with aggressive cancers is enhanced.The ultimate goal is to make clinical trial enrollment as easy as the standard of care. This innovative model is a significant step toward that vision.

Eric Lander, MD, is a medical oncologist and hematologist at Minnesota Oncology in Minneapolis, Minnesota. Andrew McKenzie, PhD, is vice president of personalized medicine at the Sarah Cannon Research Institute and scientific director at Genospace in Nashville, Tennessee. Krish Patel, MD, is a hematologist and medical oncologist at SCRI Oncology Partners and director of lymphoma research at the Sarah Cannon Research Institute in Nashville, Tennessee.