Technology May Answer Clinical Trial Accrual Challenges

James Hamrick, MD, MPH

Accrual for clinical trials in the community setting has remained a challenging aspect of cancer research.

In the drive toward making clinical trials more accessible to patients, advances in technology used by clinicians may have a role to play, says James Hamrick, MD, MPH. If protocols can be designed to easily integrate into a community oncologist’s daily routine, clinical trial enrollment may rise, he suggests.

In an interview withTargeted Oncologyfollowing a panel presentation during the Association of Community Cancer Centers’ 44th Annual Meeting & Cancer Center Business Summit, Hamrick, senior medical director at Flatiron Health and chief of medical oncology and hematology at Kaiser Permanente of Georgia, discussed improving patient accrual and managing clinical trials in the community setting.

Targeted Oncology:How can patient accrual be improved to get better and broader information from clinical trials?

Hamrick:Improved patient accrual is one place where technology can really help. The first thing we have to do is make sure that the trials available in the community make sense for community practices. Technology can help some with identifying patients, patient recruitment, and making sure that physicians are aware that there is a trial for the patient in front of them. At the same time, the doctors and research staff have to be excited about the trial, and they have to feel like the trial reflects the patients that they take care of in the real world. The results that we get out of the trial are going to end up benefitting the patients in their practice.

Targeted Oncology:How can this situation be improved?

Hamrick:There is a real opportunity to design trials that are more fit for the real world, and that make sense out in the community. For that, we need to make it less disruptive to the community oncologist's workday and workflow. Community oncologists are primarily taking care of patients all day. If we can design protocols that fit into the schedule of a clinical oncologist who is practicing in the community, then I think we can make it less of a disruption to their daily workflow, and we can lighten the burden on their research staff. That is going to allow more practices to open trials. For practices that have made the commitment and investment to research, more doctors within the practice will be motivated to participate in the trial and accrue patients.

I am very excited about the potential to change the way that trials are rolled out to the community so that the protocols are more community oncology-friendly and we have more energy and excitement as far as accruing.

Targeted Oncology:How do you balance the profit motive between sponsors and the clinic?

Hamrick:From the sponsor’s point of view, they are highly motivated to find the relevant cohort of patients for their trial, get them enrolled quickly, and to get high-quality data in a time-efficient manner. The way that trials are being designed now, with these rapidly-evolving cohorts and basket trials, sponsors need to know whether or not the treatment arm is working so that they can iterate on that per the design of the study. I think that by getting more efficient protocols into the community where the patients are will decrease the amount that the trials that don’t meet their accrual goals. That is a huge win for sponsors.

From the standpoint of practices, they are going to get access to more innovative trial designs like basket studies. Again, that is a win. A couple things are really beneficial in terms of investing in a clinical trial for a practice. Number 1, it simply makes you a better doctor. By the time a new chemotherapy or immunotherapy gets to the market, you may have already been using it for a few years in the trial—it forces you to stay on the cutting edge. The practice is able to make the statement, "if you seek out care at our practice, you will have access to the most cutting-edge care." It really is a win-win for sponsors and practices. Getting more innovative studies out there is a real win for these patients as well.

From the standpoint of the patients, I think patients and the market are beginning to understand that a practice that has access to high-quality cutting-edge clinical trials is a really excellent cancer practice. It is a hallmark for quality care in cancer.

Targeted Oncology:Are there any protocols that are being put in place at community practices?

Hamrick:Yes, I am very excited about the concept of pragmatic clinical trial design. What I mean by that is a design that is created to look more like the care given in the real world. There are people working now to design clinical trials with somewhat looser inclusion and exclusion criteria. They allow the investigator, who in this case is the physician, to do what they would normally do in clinical practice. Instead of being a very restrictive set of things that you need to do to manage an adverse event, for example, the doctor is able to manage it as they would per their clinical judgement. That is what happens in the real world after a drug is approved and used in a real-world population.

I am very excited about the idea of more of these pragmatic trial designs that reflect what happens in the real world because it is crucial that we understand what really happens. Once a new product moves from the tightly regulated traditional clinical trial out into the community, they are given to patients who tend to be older with more comorbidities who don't resemble patients that are usually found on a clinical trial.

Targeted Oncology: What do you hope that people take away from your presentation?

Hamrick:I hope that they are going to be inspired to think outside of the box. We know that the way we do clinical trials to date with the traditional model, while it has its use, is not leveraging the opportunity to learn from patients in the real world. I hope that people get inspired about research, and think about how they can make clinical research in the community less disruptive to the workflow. It is not just a passion for the few zealots that really believe in research, but it is something that is a part of the routine care of every patient. That conversation that is happening here is incredibly important in terms of the way we develop a learning healthcare system in cancer.

Targeted Oncology:Are there any tools being developed for helping the oncologist achieve better outcomes to meet the value standards that CMS has put in place?

Hamrick:Absolutely. One of the things that we are working on at Flatiron Health is making it easier for the oncologist to input the data they need to take care of the patient into discrete, structured fields. What I mean by that is something like a biomarker, like HER2 status in breast cancer. Rather than just writing that in the narrative of your notes, we can make it easier to put that information into a structured field that can then be used for automated reporting on things such as quality measures. We know that we cannot continue to have quality measures be a manual task for the practice, where an actual human has to curate all of the responses. We need to get the important data elements into structured data, but it cannot feel like box-checking to the clinician. That is just too slow and frustrating. It is this concept of making it easy for oncologists to enter data in a structured way, without it feeling structured. This is where technology can really help. We can leverage some of the learnings and user interface expertise that we have in some other areas of technology to improve healthcare information technology.

Targeted Oncology:What are some of the achievements that Flatiron has seen in its analysis of real-world data?

Hamrick:One of the main things that we are focusing on at Flatiron is being very transparent and scientifically rigorous on the real-world data that we produce. We have partnered with the FDA on publications related to immunotherapy in non—small cell lung cancer, and we focus a lot on the quality of real-world evidence. This is because we feel, along with other organizations, that we have an opportunity to write the playbook on how real-world data is transformed into regulatory-grade real-world evidence that is actually useful to the cancer community. We are very cognizant of the opportunity to do that, but also the responsibility to make it extremely scientifically rigorous. I point to the peer-reviewed publications that we are putting out as an opportunity for the scientific community to really understand and vet the whole concept of real-world evidence as it makes its way into the care of patients with cancer.