January 31, 2020 | Cereval’s Head of Clinical Operations didn’t start her career in the pharma industry. Instead, Laura Whitmore worked in banking, though she’ll admit she’s not a banker by nature. She’s much more interested in seeing the full scope of processes, analyzing what works and how things might be improved.

This interest manifested itself in her work as the Director of Innovation and Process Improvement at Otsuka. “I got to move through and see the process of the clinical trial and what it looked like, and got to think about what it could look like,” she says.

During this time, she says her background in banking gave her the insight to see immediate ways of improving the overall process.

“Especially moving from financial services into clinical trials, it was striking to me how paper-focused everything was when I first came on,” she says. “I’m seeing that shift now and we’re much more comfortable with electronic data. And so I continue to see that move and that excites me.”

On behalf of Clinical Research News, Marina Filshtinsky spoke with Whitmore about other ways to improve the way clinical trials are run, potential barriers to running patient-centric trials, and more.

Editor’s note: Filshtinsky, a Conference Producer at Cambridge Healthtech Institute, is planning a track dedicated to Implementing Risk-Based Monitoring at the upcoming Summit for Clinical Ops Executives (SCOPE) in Orlando, FL, February 18-21. Whitmore will be a speaker on the track. Their conversation has been edited for length and clarity.

Clinical Research News: What do you think clinical trials will look like in the next three years or maybe even five years?

Laura Whitmore: So what I think we’re going to see a shift in is the adaptation of the different technologies that we use in our everyday lives and seeing those used more and more in clinical trials. So I think that we are going to see less, maybe not in three to five years, but less of a focus on patients going to a specific clinical site, and instead we’re going to see us gathering data in many different ways, whether it’s real-world data from a smartphone tracking mechanism, or it’s the patient going to a local clinic for labs.

I think we’re going to see a shift away from the very centralized clinical trial and to one that’s much more flexible and enabled by the technology that we have.

What is one technology that will change the way we run clinical trials?

I think it’s the technology that has changed the way we live all of our lives and one you’re probably holding in your hand right now; it’s a smartphone. The computing power that we now have and the capabilities that these phones have and continue to develop, I think are going to revolutionize the way we gather data and the information that we are going to be able to have about our patients as they move through their lives so that we can figure out new and innovative ways to serve their needs.

I agree. I think that iPhones and mobile phones are like minicomputers in our hands, and they can certainly help make a switch to a hybrid status.

Correct. Which is really where we talk about that decentralized clinical trial model, when the trial truly becomes centered around the patient and the patient is able to be in the trial where they are, as opposed to going to the trial. I know the technology is not perfect and there’s still quite a few problems that we have to solve, but I also think all of those are solvable as we move forward.

We talk a lot about having a patient-centric trial, but until we start to make some of these shifts and some of these changes to use the technology, to think differently about the way a trial must be run, we won’t get to that to that point. But I do think, as I said, if I had to pick one technology that I think is going to change everything, it’s that one.

When it comes to patient-centric trials, what is the bottleneck? At what point do we kind of forget about patients’ rights or the patients’ perspective, and what is the problem that we are trying to fix when we are saying that we need to switch to patient-centric trials?

So that’s an interesting question and I think it’s not just one thing. Some of it is that we’re human beings, and as human beings we think about what we as one person might like in a clinical trial and then we generalize that to all people. And so sometimes we’re making decisions based on our experiences and not necessarily talking to actual patients who might be coming at the issues from a different perspective.

But I also think that, because of the nature of what we do as scientists, we’re very hesitant to change what we’ve done before because that’s what’s worked, and we know how much is riding on ensuring that our clinical trials are run correctly and that they can have good, clean, auditable data.

We move more slowly because of that, because we want to ensure that what we’re doing is equal to what we’ve done in the past and we want to validate if we need to, and make sure that the data is as good as it was using a more traditional method. And so that takes time, and it’s very difficult to get people to think about doing things differently. Everybody agrees that’s where we want to go, but it’s really hard to say, “I’m willing to do this on my clinical trial.”