In April, the FDA began testing a real-time clinical trial model that allows it to review safety signals as the trial is being conducted in an effort to enhance safety and increase efficiency.
Clinical trials, now a core component of oncology care delivery, force health systems to face the challenge of not only identifying eligible patients but enrolling and supporting them throughout the trial journey.
Evanston, Ill.-based Endeavor Health has opted to implement an “access point” strategy, ensuring patients receiving care at any of the system’s nine hospitals or 300 community sites across the Chicago area can learn about available clinical trials.
The system has more than 550 active trials across multiple specialties and enrolled more than 2,300 clinical trial patients in 2025.
Brian Helfand, MD, associate chief science officer, and Dhruv Bansal, MD, director of immunotherapy, spoke to Becker’s about what health systems need to know before launching a clinical trial network.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: As more health systems build decentralized oncology trial networks, do you see community-based research access becoming a competitive differentiator for health systems?
Dr. Brian Helfand: I really think that it’s how patients evaluate if they want to receive their cancer care at a given site or institution. Yes, access is important, but you don’t want to compromise on anything that’s cutting edge. That’s really the distinguishing mark of our health system, that it does permit the most cutting-edge care closest to home.
Being able to offer the latest innovative therapies, the trials, everything that is really going to distinguish that level of care is important to retaining and attracting patients. It is a fundamental part of how Endeavor has evolved. It’s always been central to our core values to say that we want to offer this, and that we will continue to offer the greatest care innovations and therapies to patients in real time.
Q: As health systems decentralize oncology research, one emerging concern is that geographic expansion alone doesn’t necessarily solve participation gaps. What barriers are you still seeing most often and how is Endeavor Health responding?
Dr. Dhruv Bansal: A lot of [clinical trial operations] is solving logistical issues throughout the entire network. The key is getting a little overstaffed than what research centers and cancer centers are traditionally used to because clinicians are busy. The more help you can give them — from talented research coordinators, research assistants — the more the trial network will blossom and flourish, and then the more patients can get on trials.
If you think of the number of steps it takes to enroll a patient on a trial, it increases my time to see that patient almost fivefold. We all know how much of a shortage there is of doctors, cancer doctors, all kinds of doctors. It’s really increasing the amount of support these doctors are getting, which was the first thing we accomplished in the last few months at Endeavor.
[Systems] cannot do this with their own staff. Anybody can work harder, but there are only so many hours within a day. Support staff is key.
Q: How is Endeavor Health measuring whether expanding clinical trials into community settings actually improves access?
BH: The obvious thing to look at for success is how many patients are enrolled in any trial. We are crushing that, to be blunt. Last year alone, over 2,300 patients were involved in trials, and that’s a huge success. On the other hand, we need to drive access both within our community and among those migrating to Endeavor and becoming new patients.
That’s really what we’re keeping track of, understanding that it’s a large system with nine hospitals and 300 different community access sites. How many patients from all over the geography are we accruing to these trials? And it is not only about where they’re located but it is important that the diversity represents our community as well.
What also distinguishes us as a community-based academic system is that we truly treat and represent our community; that spectrum of diversity is present throughout.
Sometimes that distinguishes us because when you talk about a lot of the academic centers, only certain populations [are represented] because they’re the ones who have the ability to afford to get there. I do believe that we are at an advantage because we’re in the community.
DB: We all know that in oncology, cancers behave differently in different populations. Historically, trials have enrolled almost exclusively the Caucasian population. We need more diversity because, realistically, an East Indian or an African American woman walking into my clinic, I may not know how well some approved treatments work for her. This is a big problem and we need to solve that.
Q: There’s growing criticism that oncology trial eligibility criteria remain too restrictive even as access expands geographically. Are you experiencing pressure to broaden eligibility so trials better reflect real-world community populations?
DB: It’s definitely a big need and where guidance needs to come from the FDA. If you think about how these trials are designed, pharma is incentivized to show the drug is effective and get the drug approved. They need some guidance from the FDA on how to enroll high-risk populations without being penalized.
BH: [This is] a very passionate point of mine. Sometimes when trials are set up, they’re so idealistic, and that’s why once you get the result of a trial, you almost need a second trial to replicate or validate that its [results are] actually the same in the real world.
Having looser criteria is important, or at least [criteria] that’s reflective of the community that you serve, but having very stringent criteria in trial design is also critical. You don’t want that criteria to be so restrictive that you can’t enroll patients that you believe, as a physician, will benefit.
Being a little bit more relaxed in the restrictions and doing it in real time is a possibility. That’s one of the goals at Endeavor, to streamline that process and get trials up and running as quickly as we can. Our goal is truly to have trials up within a month of the initial option and submission to our [institutional review board] processes. The capacity and number of trials we can get up and running very quickly throughout the system certainly makes us a preferred partner for a lot of industries to come to us with trials.
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