Reimagining Clinical Trials in the Community Setting

Ivy Altomare, MD, senior medical director at Flatiron Health, discusses the current state of clinical research in community oncology and how technologies and new models are changing clinical research. Her presentation was part of the panel titled “Reimagining Clinical Trials in the Community Setting” at the 2023 Clinical Pathways Congress + Cancer Care Business Exchange.

Transcript:

Ivy Altomare: I'm Dr Ivy Altomare. I am a medical oncologist and I am a senior medical director at Flatiron Health.

Can you talk about why cancer clinical trials are moving toward the community setting?

Dr Altomare: There are an ever-expanding number of cancer drugs in development, which is great for patients. But that means that there are an ever-expanding number of clinical trials every year. And we know that very few patients actually enroll in clinical trials. The percentage varies by different estimates, but it's anywhere between 3% and 8%, which is still pretty dismal. And unfortunately, that's not really getting better as time goes on.

For the community sites to participate in clinical research, they serve as a huge, really untapped resource to increase the numbers of patients that go on study, but more importantly, to potentially improve the diversity and the representativeness of the patients that are enrolled and participate in trials.

And not just with race and ethnicity, but age, performance status, comorbidities, socioeconomic status. We know that trial participants at academic medical centers are really overrepresented in terms of being at the highest socioeconomic status level.

So, there is huge momentum and industry recognition that increasing trial participation in the community could really address these inequities.

One of the barriers is, of course, the huge burden of conducting quality research in the community. It takes a lot of resources, it takes a lot of time. It takes time away from patient care. And there are several community oncology practices that run really fantastic research programs, but that's not without effort. And so that's where technology can really help to facilitate the process.

Can you expand on what opportunities exist for technology to help tackle clinical research challenges?

Dr  Altomare: Technology has the ability to really potentially accelerate clinical research operations, really at all elements of clinical trial execution. So there are technology tools that can help with feasibility analysis. So helping a site look at the data that they have in their electronic health record in order to find out if they have the patient population that matches a potential trial. So that they're able to make an informed decision about the trials that they open based on the patients at their actual practice.

Then there are tools that assist with patient matching. So once a site decides that they would like to open the trial, then you need to find the patients and enroll them on studies. And in the context of busy practice, busy day, sometimes it's easy to miss surfacing the trial opportunity to a patient at the right time in their care.

So there are software and tools, again, powered by the data from the electronic health record that is able to assist in screening patients, surface which patients would be potentially eligible, and then sometimes even kicking back with notifications at the point of care for the clinicians to know, oh, this patient's sitting in front of me. We actually have a trial that's open at our practice that they might be eligible for.

Then there are tools and software that really allow for decentralization of clinical trials. So that the activities of a clinical study, certain activities don't have to happen within the walls of the cancer clinic. So there are tools for electronic consent of patients. There are tools for enabling remote monitoring, and these are not new. They're very prevalent. And especially during covid, they became very highly utilized.

There are also tools or applications on smartphones that allow for patient-generated data to be collected in the context of a clinical trial. So all of this technology can really help to facilitate, enhance, and streamline clinical trial operations.

One of the technology tools that I'm most excited about is tools that really facilitate the capture of trial data for a patient. It is astounding that the average late-phase prospective clinical trial requires the capture of 3.5 million individual data points during the duration of the study. So that is a huge burden on site staff to have to enter all of that data in a timely and accurate fashion.

And it turns out that a lot of that data is actually manually copied directly from the electronic health record. So people are spending their time typing numbers into boxes when, if there was a way to automatically electronically transfer that data, it would happen much faster. It would be 100% percent accurate if you're selecting the right data elements to transfer, and now these tools exist. So I feel like these are really going to revolutionize clinical trial operations, and hopefully we'll see more widespread adoption of these types of technological tools as time goes on.

Technology has the ability to improve things and it also introduces its own challenges sometimes. What we want to avoid is, we don't want research teams to have to use five or six different applications with different passwords and different logins and learn all sorts of different systems in order to follow the patient through the trial.

It is optimal for this technology to be interoperable with the EHR, or even better, embedded in the EHR so that it is one login, it is one system. It aligns with the workflows of the clinician and the research team, and you don't have to go through multiple separate systems because that can be a deterrent to the application, widespread adoption of technology.

Can you provide some real-world examples of technology tools in action?

Dr Altomare: There is a large multicenter global study, basket study from a top 20 biopharma sponsor, that was having difficulty enrolling patients in certain of the arms of the study because it was a molecularly-restricted patient population for each of the arms. And it was just rare alterations that the patients would have to have to be eligible for certain arms of the study.

This pharma sponsor leveraged the tech abilities of 15 community oncology sites, which were a really small number of sites in comparison to all of the sites in this global trial. And used a tech-enabled way to have patient matching through mining of EHR data, such that patients with one of these rare biomarkers was then surfaced as potentially eligible, and a point of care message was sent to the clinician.

And through the deployment of the tech, and also the operations of the notifications to the physician, this process resulted in 10% of the total accruals of this entire global trial. And that came from just a small handful of community sites. So it really can show the impact that this kind of technology, when it's adopted, can really have.