Pennsylvania Hospital Shows That Community Cancer Centers Can Conduct Phase I Clinical Research

Tara Perloff, Oncology Clinical Research Program Manager, Penn Medicine Abramson Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, joins Pharmacy Times at the Association of Community Cancer Centers' (ACCC) 40th National Oncology Conference, happening October 4 through 6, 2023, in Austin, Texas, to discuss how her community hospital created a successful phase 1 research program. She touches on the main differences between research conducted at an academic versus nonacademic setting, the organization’s recruitment methods, and the importance of integrating the pharmacist into the research team.

Pharmacy Times: When it comes to recruitment and conducting phase 1 research trials, how is the community cancer center different than the traditional academic treatment center?

Tara Perloff: Pennsylvania Hospital is part of the University of Pennsylvania health system. We are a separate community practice setting, so even though we're part of the cancer center matrix of the Abramson Cancer Center, our practice is set up just like a typical community practice model, such that we do not have subspecialized research departments like an academic institution would. We’ve created our own infrastructure to be able to do the kind of research that we want to offer our patients. We want to extend access to cutting edge research to phase 1 clinical trials throughout the health system. So, even though patients can have access to many clinical trials in our primary location, this is really just an extension of that to offer more options for patients who may not otherwise have access given some of the travel restrictions.

Pharmacy Times: Why might the pathos and ethos of an academic-led cancer program be different than that of a nonacademic-led program? Why or how could it impact enrollment?

Tara Perloff: From probably a sponsor driven perspective as to why they would want to open a trial at an academic institution versus a community practice, their reasons are obvious. They need compliant data, they need an institution that has the resources that has done this and has experience. First and foremost, they want to make sure that the team is experienced to treat patients safely on some of these very complex protocols. And we know these protocols—not only in research, but even standard of care—things are getting more complex, the agents are getting more complex, the combinations become more toxic. Starting from the top as to why, there may be a hesitation to work with community sites, I think it's probably just that regulatory quality assurance compliance.

However, I think there's a million benefits to conducting research in the community setting. First and foremost, it's the patients, not all patients are able to travel or have the means to travel to an academic institution to receive access to a clinical trial. Patients want to stay close to home, [they] want to stay with their current provider. What we've really found and has been our success point with this program is not modeling things off of an academic institution, because we'll never be an academic institution. We had to develop our own infrastructure that worked for us, not just as a cancer center, but as a private institution, as a hospital research program where we don't have subspecialized departments, but we can make this work. It doesn't happen overnight. I think starting small, starting with a pilot and learning as you grow, setting measurable goals, making sure that you're holding yourself and your team accountable for those goals.

From the patient side, it's all about right patient, choosing the right trials, having the right physicians within your practice, and making sure that it's the right time, that you have the right resources in place to safely treat patients on these protocols. Also, all of the other requirements for research—like data—and making sure that there's also a time commitment, resources, and financial support available to conduct these types of studies.

Pharmacy Times: How does the format of the phase 1 trial differ between an academic and nonacademic-led program?

Tara Perloff: University of Pennsylvania, a large academic institution, has been conducting research for years and it conducts complex research in many different domains. When you think about an institution that has subspecialized resources for research, it's not just oncology, so, that has been established for a long time. There's units for tumor tissue banking, some more of the inpatient phase 1 clinical trials. It's very subspecialized, and that's just not realistic for a smaller community cancer center that is still part of a hospital and still has a network within that large institution, but we’re not going to have those subspecialized resources. I don't think that we need to, I think it really comes down to innovation and how you can make something work with what you have.

Pharmacy Times: What can pharmacy oncologists do to support the spread of this enrollment model for phase 1 clinical research trials?

Tara Perloff: Similarly, our pharmacy has—although we have close collaborations with our large institution—really established our own SOPs and our own processes. I think the most successful thing for us is having our research pharmacist fully integrated with our research team. So we’re really bringing them in at the time of feasibility. When we’re asked to participate in a certain protocol, making sure that it's not just the physicians and the research team, or the research managers looking at a study saying, “Okay, like, this looks good, let's open this trial.” We’re making sure that the pharmacist is looking at that investigators brochure, that they have the opportunity to connect with the medical monitor to really understand what are the preparation requirements. Do we have the right facilities? Can we store this? Do we have the right oversight? What are the administration requirements? Oftentimes, if it's a phase 1 study, we have to adapt our hours, so if a pharmacist typically comes in at 8am, they may need to come in at 7am or even 6:30am if that drug requires certain preparation for that cycle 1 day 1. So, really involving them in all aspects of the program at those early stages is critical and getting that multistakeholder buy-in, which includes the pharmacists.

Depending on the program, sometimes we have our pharmacists do patient education. So, specific to an investigational product, if we're having the pharmacist meet with the patient to explain some of the risks of that particular drug, that's another component that we want to make sure this study works for everyone because if your pharmacist isn't really aware of it, if they find out after the fact, it causes issues for your whole system. When people have to come in early and stay late, it's not something that they signed up for. I think it makes a big difference to have that close-knit relationship with pharmacy and really consider them part of your research team.