Is That Tech You're Eyeing Really Worth It?

A conversation with Jakob Alme, head of digital health, Sage Therapeutics

How, when, and why pharmaceutical companies choose a technology to improve their clinical operations is a complex process, to say the least. That’s why we spoke with Sage Therapeutics’ head of digital health to help us understand the questions companies might think about relating to the return on investment — financial or otherwise — when they consider adopting a new technology.

Usually, we think about return on investment in the traditional sense of profitability, but when it comes to digital technology in clinical research, should we be thinking about ROI differently?

The profitability formula and outlining the financial gain you're getting by implementing a technology is absolutely something that should be done. But often there's a less bottom-line-focused value that implementing something digitally forward can do for something like efficiency gains, making something easier for your employees, or unlocking something that wasn't possible before. I would say it's a combination of the two — the financial bottom line and the physical return on your investment. But there's also other things worth considering in the decision-making process — should we invest in this, should we explore this, or is it better to do something else

Is there anything you have observed in your current work that did just that?

I can think of two examples. The first is the hallmark of the migration from traditional paper and pen data capture, whether it was patient-reported outcomes or the case report forms, to something that's electronic.

What did that do other than changing the modality of collection? Well, it reduced the human error related to entry and transcription. It also reduced the amount of effort. Someone didn't have to physically write down exactly what they were seeing in the study or data they were collecting, and they didn't have to reenter it in an electronic data capture system or physically put it in the mail anymore. It also reduced the manual work associated with filings, data traceability, and documentation continuity. And all of those steps can be translated to a monetary or efficiency gain, but it probably made everyone dealing with those things a little bit happier. It's not to say that the transition was flawless. Of course, it created more complexities. Sites have to deal with multiple sponsors and portal logins, and that's its own issue. But I would say the net gain was the ultimate value driver for the implementation.

And the second is related to the value creation of doing something that wasn't possible before. A tangible example of that is looking for cognition-related data on a specific asset. It's typically difficult to do because the placebo effect in neuropsychiatric research is so high. You also have variability in the way you're capturing data, the responses from patients, and the scales used to measure them in the clinical guidelines. So, how can you objectively understand more about that cognition-related aspect? Digital technology, like augmented reality and cognitive battery assessments, is now an emerging field, and that may be something you can use to supplement those original techniques. At the very least, it's worth looking into because you might glean more information about your patients, your population, your drug, the disease state, etc., than you would've had access to in the past.

Of all the available technologies, are any a sure bet for sponsor companies to adopt?

I don't know if “sure bet” and biotech can be used in the same sentence very often. That being said, there are things that are pretty consistent throughout the industry. EDC, IRT, eSource, and electronic contracting systems are becoming table stakes to participate.

Sponsor companies should assess their organizational needs. Some of them you won't even need to ask that question because it's so obvious — they have to use an EDC because that's what the sites that have access to the target patients are used to using. But in that a la carte menu of all the digital things, they’ll probably end up picking and choosing the ones that make the most sense for what they’re trying to accomplish.

Ideally, you would have the problem identified long before you ever choose the technology, but that's not always the case because new innovations are coming out all the time. There is that occasional scenario where you do it backward; you have a great set of technology that you assess whether its capabilities fit the bill.

Digital endpoints are increasingly considered for use in clinical trials. But what can they offer above and beyond traditional endpoints?

Ideally, they should be offering the same thing. If you do it right, it will be an endpoint that stands by itself. The question is which direction you are heading. Are you doing something that's been done before, just in a different way, or are you doing something that's entirely different and new? The second is a lot harder. That's where people get stuck. There might be an interesting characteristic of the pathophysiology of the disease they want to measure and, until now, it hasn't been possible.

If no one else has done it before, that's a pretty high bar because it's got to be compared to what's been done in the disease state, and there's going to be conversations with regulators, KOLs, and scientific folks about whether this is valid. But at the end of the day, if you've done it all right, it should be the same as a regular endpoint. The digital should be unimportant at that point. It also depends what sort of threshold you're trying to achieve. Digital endpoints and biomarkers don't always necessarily mean label enabling or contributing to a regulatory submission. You may do it just for informative purposes, and that's okay, too.

Are clinical researchers eager to adopt digital endpoints, or are there challenges or hesitations?

Some people are really excited about them and their potential, and I'm one of those people. It is truly transformative the way we continuously evolve how we measure, characterize, and understand what is happening in a clinical trial. But you also have to recognize the people who are a bit more pessimistic and reliant on traditional methods. Those methods aren't going away. Just like any adoption, there will be a smoothing out period as people get more used to it just in time for the next disruption to come along and start the process again.

It sounds like education is a key component of a technology’s success. Should that come from the sponsor company?

There are also lots of academic centers and sites that are doing these things themselves, and it's not always the sponsor originating them. It's not always the sponsor filtering down the decisions and then requiring it of the sites. But I do feel that we'll probably reach a breaking point of the sort like eSource and clinical trial management system portals, which sites are having to log in to now. No matter what site you talk to across the world, we will reach a breaking point, and something will have to be developed that can fix that issue so it's not so burdensome.

Speaking of the patients, are there any technologies that can facilitate more diverse clinical trials?

The first one is smartphone access and provisioning devices connected to cell service or the internet. It's the low hanging fruit. But the number one thing is for patients to have access to resources like transportation to and from the site and to be able to submit questions for their coordinator and report adverse events.

The second is changing where research is done — that hybridization or decentralization of clinical trials — and ensuring the same level of data quality and integrity as a brick-and-mortar site. It's especially important in hard-to-reach patient populations that are older, very remote, or have a rare disease. If you can recruit a patient 6 hours away from the nearest site and confidently collect data on them and their experience, that's a gamechanger. Now you've expanded your perimeter geographically and have people that are 6 to 12 hours away participating. And if you set it up the right way, you’ll still have the authority of the PI and oversight that you would expect of a traditional brick-and-mortar site.

And third, the pharma industry is six steps behind whatever the tech industry is doing. And that's for a good reason most of the time. It takes a little bit longer for us to figure out whether those things are safe to introduce to patients and use. But the “consumer” experience in clinical research is awful. No one knows that clinical trials exist. Sometimes clinicians will refer patients to one that's relevant, but unless you know that clinicaltrials.gov exists or you get a targeted ad, how on earth would you ever know that that's an option for you?

And even if you qualify and then you join the study, it's still a chaotic one-sided process. You don't hear a ton from the site side unless you reach out or they need something from you. It's very transactional. And what would we expect a consumer experience to look like that would entice or convince someone that it would be worth participating, even if it is going to be the best choice medically for them, when it may be so disruptive to their daily life that they just can't participate? We have a lot to do to get to the point where it's as seamless as our shopping experiences — I know my options, and I know what they have in stock.

We are so far from that vision of seamless experience that it's almost hard to imagine being that way. We don't have to replicate the traditional store or online shopping experience, but we should strive for something that gives people a reason to participate in it or want to contribute. It’s a long way to go, but I’m optimistic that we'll get there.

About The Expert:

Jakob Alme joined Sage Therapeutics in 2021. As the Head of Digital Health, he is focused on rethinking care and how it is delivered to help patients and families impacted by brain health disorders. In this role, he leads the function’s efforts in implementing digital health strategies across the organization, ranging from preclinical and translational through development, commercialization, and on-market planning. Prior to his time at Sage, Mr. Alme led the digital health asset design for immunology at AbbVie, and also held roles in clinical operations, compliance, and data sciences. He holds a BS in health and human performance from the University of Montana.