Telehealth Utilization in Clinical Trial Research and Participation

Matthew Lunning, DO, FACP, University of Nebraska Medical Center, discusses the expansion of telehealth during the “COVID era,” highlighting the importance of face-to-face encounters between patients and health care providers, and suggesting ways to successfully meet this demand in clinical trials utilizing telehealth.

Transcript

So I was asked to speak about telehealth and its utilization in clinical trial participation, in clinical trial research. And I think that this has a two-part story. In my household we kind of live by a “BC” and “AC”—“Before COVID” and “After COVID.” And I think one of the things that I showed during my talk is that telehealth was already there before the COVID era, whether or not it was being implemented in cardiovascular research, pain research, but it was also being implemented in oncology. Specifically, one of the studies I showed was in palliative care, just how important it is to have a team approach, one that allows you to reach out to the patient or the patient's family, less so in a phone call environment, but more so in the eyes of a face-to-face encounter, and whether or not that face-to-face encounter is virtually or coming to their home.

And that study showed that face-to-face encounters were incredibly effective, more effective than just a phone call. I then highlighted the use of iPads by the VA, by distribution to veterans iPads, that was incredibly successful from the implementation. The user, who would be the VA patient, really loved having access. One of the challenges was, though, is that on the backend you have to have the support staff in place for when those veterans wanted to use a virtual telehealth like Modality. That was incredibly important to have the backend service, not only just giving them a fancy, shiny new iPad. And then I transitioned into the period of time, which was COVID. We are in 2AC, if you will, from that, so roughly 2 years post-COVID. And how has telehealth really transcended, and COVID, transcended clinical research? There's a period of time in my own institution where you could not do face-to-face clinical research, unless it was related to COVID therapeutics, or it was in a situation where the research had the prospect of direct benefit and was crucial to the outcomes of those individuals with cancer.

And really, we had to learn how to do clinical trials either in a face-to-face environment with PPE, or we had to learn to do clinical trials through a virtual media. Now I think all of us probably in the last week have been offered to be on a Zoom, or have been on a Zoom or Microsoft Teams-like virtual platform. And one of those things that we know is that really there's an extra level of engagement when the camera is on and when you're able to speak. And I think we can utilize that in the clinical trial perspective, to enhance not only the understanding of the clinical trial, but the engagement and the commitment to the potential subject, whether or not that research is minimal risk, or whether or not we can do certain minimal risk procedures that then allow for interest and engagement and potentially further understanding of the clinical research. And then if that clinical research is greater than minimal risk research, then when they come to their next face-to-face encounter, that face-to-face encounter is meaningful. And you can go further into the informed consent and answer questions.

I lastly kind of showed a human biologics material consent, that I personally wrote with the assistance of several colleagues in the regulatory domain at my own institution. Looking at how we use e-consenting, as well as telehealth, through a visual, as well as speaking type of a modality, to allow reduction of face-to-face contact in a minimal risk study. But when they came in for their clinical assessment, that we were able to get baseline blood work, kind of in that peri-COVID arena, when not a lot of data was known, and we felt there was an opportunity at Nebraska to get baseline samples, understanding that our COVID population was likely to increase over time, specifically the oncology population. And we were concerned that the outcomes of those individuals would be affected drastically. And I think the data has bore out and we've learned a lot over that time. But we wanted to be able to have those baseline samples, but without putting the subject at increased risk by asking them to come in for a research-only test.

And so that had been successful. And now we're looking at ways to implement telehealth, e-consenting. One of the barriers, I think, is around Part 11 compliance, and whether or not this is to do FDA-regulated or federally funded research. Having those pieces in place is what allows you to go to the next level. And I think each institution has to deal with that process perhaps differently, just because each institution through regulations and their IRBs and the Office of Regulatory Affairs, may be different.

But I think overall, doing clinical research in the pandemic, there were lots of trials and tribulations. But I think we have an opportunity, because within the research infrastructure during the pandemic was clinical research. And without clinical research during the pandemic, we would not have drugs like remdesivir, baricitinib. We certainly wouldn't have our vaccines. And arguably, it was those therapies through clinical research that allowed us to be pulled out and sail, if you will, with the pandemic, but keeping our heads above water.