Purpose-Built Trials: Designing for Greater Patient Access

A clinical trial can offer patients access to therapies that may not yet be available through standard treatment, but the ability to participate often depends on where a patient lives and where they receive care. As oncology continues to move more treatment into community settings, Krish Patel, MD, emphasizes the importance of designing “purpose-built” trials—studies developed with accessibility and real-world delivery in mind—to help close that gap.

In an interview with Targeted Oncology^TM, Patel, executive director of hematologic cancer research at Sarah Cannon Research Institute (SCRI), discussed the role of community oncologists in expanding clinical trial access and how more decentralized and “purpose-built” trials could make clinical research more accessible.

Targeted Oncology: What are the general advantages of clinical trial-based care? What should community oncologists know if they have a patient they would like to refer to a trial?

Krish Patel, MD: I think there's a huge number of advantages in clinical trial-based care. Every therapy that's ultimately approved for use has to go through clinical trials to then be ultimately approved. What I think clinical trials offer that is important for [both] patients and practitioners to know about is that they may offer the earliest access to cutting-edge therapies for patients, but they also do so in a very structured and safe way. There's a lot of built-in assessments in a clinical trial to make sure that, first and foremost, patients are being cared for safely, and that we're able to navigate any new or unexpected [adverse] effects that arise from new medicines. They often also build in very close monitoring; it's really important for us to understand how these new therapies perform relative to established ones. My own experience has been that patients get extra layers of support as they participate in clinical trials, and so hopefully, what can seem like a scary proposition actually feels like a much more comfortable one for patients who have gone through that experience before.

I think the thing that's important for community oncologists to know is that they're a vital part of conducting clinical trials. Our organization really advocates for the inclusion of community oncology sites in clinical trials so that patients can access those therapies where they live; they don't have to travel to sites that may be remote or distant. Community oncologists [play] a really important role there. Also, there may be trials that can't be operated entirely in the community setting, and so to be aware of what is available in partner networks or sites that may be adjacent to where community oncologists are practicing is important.

What do you think clinicians sometimes underestimate or misunderstand about clinical trial participation?

Clinical trials should be an option, really, at any point in the patient's journey. We have trials that fulfill the needs of patients who are starting their very first experience with cancer treatment, all the way to patients who may not have any other options in the approved toolbox for use. And so, a misnomer to dispel is that clinical trials are a last resort. In fact, in many instances, I think they really should be a first consideration because of the speed at which new medicines and new therapies are being developed for the benefit of patients.

Do you think oncology as a field has done enough to make clinical trials accessible to patients who need them most? What would you change about the way clinical trials are designed or conducted today?

When we think about the stakeholders who are able to influence that accessibility, we think about the sponsors of clinical trials, the organizations that conduct clinical trials and how they support sites, and then importantly, regulatory agencies. I think all of those stakeholders have to come together in a way that makes these trials as accessible as possible. We recognize that not every community oncology site has the same capabilities, but they hold the largest volume of patients who really need to access and be a part of these clinical trials to help us move things forward. So, I would say there's a lot of work still to be done in thinking about, are all the [criteria] that we have traditionally required in trials really necessary to help us answer the question about whether a new medicine is safe and effective? And starting from that question to then think about all the procedures our patients might go through and all of the operational considerations, and that really is a partnership between all of those entities.

I think one thing that's exciting to think about is the potential for more decentralized trials. For example, certain safety assessments, labs, things that are done on trials—can some of those be done with a community oncologist, even if they are not a participating site in the trial? If that ultimately means more patients can participate in the trial, we end up getting the same data collected and the same information that's needed to make sure therapies are safe and effective. And so, I think there is a lot of emphasis and effort on trying to think about, how do we make trials easier to access? That's certainly something that, at SCRI, we think about every day. I think you have to start with that framework: What are the absolute necessary things to answer the most important question? Is the study showing that a new therapy is safe and is it effective? Then work backwards from there to make sure that those operational characteristics align. What we find is when we do that, a lot of community oncology sites can effectively participate in clinical trials, but we have to think about what I would call “purpose-built” trials: trials that are designed with the intent to make them accessible, to make them deliverable in the communities where patients are getting their care.