January 21, 2020 | “I guess you could call me a clinical operations expert,” Jane Myles, Founder and Director of JemTech, tells Clinical Research News.

After beginning to design and execute protocols as part of knowledge tool teams, Myles now helps plan for and then execute innovation in patient recruitment, leveraging data and technology wherever they believe it can help patients. Myles says this has been the focus of her entire career.

On behalf of Clinical Research News, Bridget Kotelly spoke with Myles about the challenges in clinical trials today.

Editor’s note: Kotelly, a Conference Producer at Cambridge Healthtech Institute, is producing a track dedicated to Feasibility & Site Selection at the upcoming Clinical Trial Innovation Summit in Cambridge, MA, April 6-8. Myles will be moderating a panel on the program. Their conversation has been edited for length and clarity.

Clinical Research News: What do you think about the challenges in clinical trials today and why is that?

Jane Myles: I think there are a whole lot of opposing factors right now. The first I think is that there are a lot of patients who are willing and interested to participate in trials, and yet they don’t seem to have the awareness of specific trials or access to those trials for a multitude of reasons, one of the most important being geographic limitations.

That’s number one. Trials are slower than they need to be simply because patients don’t know about them or can’t get to them.

Another factor is that we have access to huge new datasets to help us design and implement trials. I think that’s really exciting, but the challenging part of it is not all of that data has been curated or is easy to use. While it may be available, it isn’t always easy to use to drive decision making in order to make those trials more efficient or simple.

And then the third factor is a bigger issue, which is the cost of implementing and executing trials. Costs continue to increase, and what worries me is that, despite the new data availability and patient interest, with cost constraints we might actually fail to execute trials on amazing molecular targets that could help patients. I think we have an opportunity to leverage all of those factors to do better.

You mentioned specifically technology and improving engagement and execution. Can you explain a little bit more around what innovations you think will work towards those goals? What has you most excited?

The way I like to think about it is, to quote my colleague Kelly McKee, figuring out how to leverage technology to make it a “choose-your-own-adventure” experience to be in a trial. That easier said than done, but let me explain. We have access to lots of different off-the-shelf technologies now in our regular lives, such as automated appointment scheduling with your Apple support team or an app that reminds you that it’s time to go to the doctor. What we haven’t done well in the industry is figuring out how to use those technologies in ways that can actually help both the sites and the patients without continually adding more buttons to click, more URLs to follow, and more tools.

What I’m really interested in is figuring out how to allow patients and sites to use these technologies so that we can actually drive down costs, increase accessibility, and improve awareness. But that’s the tricky part here: how do you view that in a way that is integrated and uses input from both the sites and patients? Who are the key stakeholders to help us drive adoption?

I guess the stakeholder I’ve left out of this conversation so far are the regulators. The reason I’ve left them out is not because it isn’t a challenge, but rather because I keep hearing from regulators in both the US and the EU that they’re really interested in advancing trials to be more patient friendly and to leverage these new technologies, both so they can gain access to deeper and more accurate data sets and to drive trial efficiency and speed.

If you had a magic wand and could make anything happen to change things for the better, what would it be?

Well, I guess I’d really be interested in gathering up all of those options into one integrated solution—I’m thinking a little bit magically here—that went across industry so that patients could actually be matched to the best available trials, not just by sponsor but for their own specific needs.

So there would be trials that were... hybridized and allowed patients to participate both at brick and mortar sites, and in virtual or tele-remote settings that include the passive data collection elements that we’re also interested in. So now I’ve just put in a whole lot of concepts here…. I guess what I’m saying is my magic wand would allow trials to be much more patient and site-friendly, leveraging of all these available technologies in a way that becomes the regulatory norm.