A Close Look at Clinical Trials in Oncology and Beyond: Boosting Accessibility

In this episode of OncChats: A Close Look at Clinical Trials in Oncology and Beyond, Christina Brennan, MD, MBA, FACRP, and Richard D. Carvajal, MD, of Northwell Health and Northwell’s Feinstein Institutes for Medical Research, emphasize the importance of providing flexible trial options, such as satellite sites and remote follow-ups, to enhance recruitment and retention, while underscoring the importance of patient choice and lessons learned from the shift toward decentralized trials during the COVID-19 pandemic.

Brennan: Yeah, I agree. First, looking at Northwell, as large as Northwell is [with] 21 hospitals and over 900 ambulatory sites, maybe not every center can participate in research, but at least they could be perhaps a satellite site where some follow-ups can take place. This way, it gives patients options, because patients often complain about traveling, even to academic medical centers, where some of these trials are taking place. They just can’t keep getting there, which [leads to poor] compliance for follow-up. I feel if we give patients options, whether it’s going to one location for the initial enrollment [and then] perhaps some of the follow-ups and treatment can be [given] at a different center, this [would] improve a lot of the recruitment and retention. [This would] increase the pool of investigators, as well. Like you said, they can have some participation; it doesn’t mean that it’s the same [level] as maybe [what we would see at] the primary location.

When we think about that, this is what comes to mind to me, but you can tell me what you think. We’ve heard a lot in the industry, especially during [the] COVID-19 [pandemic about] DCTs, decentralized clinical trials, and I didn’t particularly like the term, [but] it was something that the FDA really redefined and kept moving forward with. We had to pivot during [the pandemic] to a lot of remote environments and [we needed to] continue to make sure patients were receiving treatment and being followed. Now, moving forward, just as we’re saying coming to the study location for one aspect of the trial but giving the patient the option [of going to a center that is more convenient, we raise the question], can some of those follow-ups be done at the patients’ homes? We’ve done this at Northwell, and I think that would also go a long way in the clinical trial space [with regard to] patient satisfaction.

[However,] not everyone wants a visit at home. I remember something funny. We did a survey on [female] patients having visits at their homes for part of their clinical trials. Believe it or not, some of the women said, “I don’t want people coming to my home. I felt I had to clean before I could have a visit.” That could be true [for some]; it added another layer of stress or burden on the patient because they felt they had to have their house in order. As such, I keep saying patient choice, patient centricity [is key]; I don’t think clinical [trial] protocols can be so black and white. I think [there needs] to be options for our patients.

Carvajal: Northwell [was] such a leader in that COVID-19 [pandemic] space [with regard to determining] how to actually do these sorts of trials in that environment. [For example,] the famotidine trial; it was pretty amazing that you were able to design and pull that off as quickly as you did.

Brennan: Yeah, that is a great example. Just to give the audience some perspective, this was a trial that we did during [the pandemic and explored] famotidine, which is the active ingredient in Pepcid, which many of us know is an over-the-counter, gastrointestinal type of drug. We were originally going to have this as an outpatient trial, recognizing then that the last thing a patient wanted to do when they had COVID-19 and were feeling pretty sick was to keep coming back and forth to the hospital or the clinic. As such, we completely pivoted the trial to a fully remote trial, and we were able to utilize Northwell’s resources. We recognized our laboratory groups were already going to the patients’ homes, so that was an easy win. We worked with pharmacy [to ensure] drug delivery to the patients’ homes, so that was [another] win. And then, we were able to provide the patients with electronic tablets so that they could provide patient-reported outcomes to us in real time. We really did a good job in showing that [a trial] was [able] to be fully remote. Once we really measured our data, we found that we reached patients in zip codes who never participated in clinical trials with us at all.

Carvajal: What an amazing lesson. In the cancer space, when the pandemic hit, even our most challenging or complex trials, these phase 1 trials, we figured out how to make them happen so that patients didn’t have to come in as frequently. In a way, it forced us to look at what’s really necessary in these trials to actually answer the question.