The Call to Action on DCTs: No Going Back

March 31, 2022

We’ve all lived through more than two years we never imagined. A good friend of mine likens it to a prolonged episode of Black Mirror.

I remember sitting at this desk, in this chair, in March 2020, one month into a new job to drive the adoption of Decentralized Trials at scale, and wondering what the heck was coming next. The news cycle was speeding up and we were all seeking information. The world was slowing down in many ways, like office closures, travel bans, and supply chain crises.

Clinical trials were in a free fall. What the heck was coming next?

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Early Perspectives on DCT Adoption

I distinctly remember having my light bulb moment. And it was in no way an original thought. Luckily, I was working with fantastic people who were collectively having similar light bulb moments:This pandemic was the catalyst to move DCTs from theory and pilots to action and adoption.

By that time, I’d been working on driving the use of patient and site-facing technologies into trials for a while - about a decade! It was slow, painful work that required a lot of intestinal fortitude and resilience to work with every individual project team and answer the same questions repeatedly. Some of which included:

Q: What’s in it for me / What’s the ROI?
A: Due to slow adoption rates, there isn’t published data on this yet. However, moving towards DCT is the right move.

Q: How are regulators going to respond to this?
A: We don’t know, but we can ask what it will take for this to meet their expectations.

Q: What do sites think?
(in retrospect): To be fair, we didn’t ask them enough.

Which often led to: My trial is different and unique. I can’t take this risk.

These conversations helped me learn a lot about what it takes to drive understanding, adoption, and scale (and I have ADKAR methods burnt into my being).

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The Shift

As health-system resources became consumed by COVID-19-related care and travel became limited by physical distancing, patients’ access to trial sites was reduced by 80 percent (1). By Q4 of that year, 55% of active, ongoing trials had transitioned to at least one DCT solution (2).

Telemedicine was the most often-used solution, and 60% of investigative sites reported having no prior experience with remote processes and solutions before the pandemic. That’s a huge disruption - and it was the sort of frameshift that was needed to keep patients in trials and keep those trials going, even with some changes to study assessments and data collection approaches.

There were some really important contributing factors to all this DCT use in pandemic conditions. Regulators like the FDA and EMA worked very hard to create guidance on how to continue trials, what to do when seeking approval for amendments to use DCT solutions, and how those solutions could be used in a compliant manner.

In the U.S., changes were made to make it easier for MDs and investigators to be paid for medical visits done using telemedicine. It became easier to ship clinical supplies to participants’ homes with all the required documentation and chain of custody needs in place. So the pandemic enabled a series of ecosystem changes that helped sponsors and CROs implement the use of DCT solutions.

In the same timeframe, there was a big increase in the number of service providers offering DCT solutions. In fact, the use of the term DCT has been a bit confusing, as it can mean anything from point solutions like e-consent, in-home health services, and e-clinical outcome assessments, to end-to-end virtual trial management.

Some providers offer only one of the DCT solutions. Others, like Curebase, offer full clinical trial services, virtual and hybrid site solutions, and a comprehensive software platform. In fact, over the past four years, Curebase has run more than 40 trials using a variety of platform-based technology solutions and clinical trial support solutions.

It’s all about the right blend of high tech and high touch to make the trial workable and ensure all the scientific needs of the trial are met.

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Where is the DCT Landscape Currently At?

The pandemic was just the catalyst we needed to move teams to use DCT solutions, even if it was a retro-fit, rather than a built-in design element to their trials.

There has been a massive increase in the use of those DCT solutions in the past two years, and it’s going to be very interesting to start to have those metrics about ROI, cost, time, and impact from those trials that shifted to use them.

It won’t be a perfect lens - but in many cases, we’ll get to see the impact of those changes within-trial; in effect, the trial acts as its own control arm pre-and-post DCT solution implementation.

Some of this data will be gathered and shared by the DTRA Evidence of Impact workstream. They’re collecting data right now at this link if you have any to share!

The current landscape makes me think about the Gartner Hype Cycle. We are probably about “at the peak” on this graph re: suppliers and adoption. And that means we’re at risk of sliding into the trough.

It’s important to remember that most of the trials that were the first DCT experience for investigators had not planned to use those DCT solutions. They were adapted, on the fly, to allow the trials to continue. The trials had not been designed with those solutions in mind, sites and investigators literally had to learn by doing. Those factors may have contributed to the data in the graph below, compiled by McKinsey.

What concerns me is the trend, across the board, to assume that there will be a big decrease in the use of virtual interactions in trials. Now some of that is to be expected - we literally could not visit clinics and research sites for a significant time during pandemic lock-down conditions.

However, we definitely can (and in my opinion, need to) do better at allowing patients optionality in trial participation by leveraging DCT solutions and services.

Patients expect better trial designs. Not everyone is a digital native, but almost everyone uses technology as part of their daily lives now. There’s growing evidence that the digital divide is more about access than willingness or age. So if patients want to use technology, and the technology can be used widely, it’s time to design and execute trials with patient optionality, through technology and services, as the standard.

The opportunity is in our hands to ensure that we can and do speed the development of new medicines by leveraging these tools and technologies.

Patients are willing. Sites are ready to learn. Regulators have been willing and may need a signal that we are all ready to move forward with these new approaches as the way we do trials. It’s our collective call to action - There is no going back.

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Learn more about DCT and Curebase study models in this blog: The value of learning by doing

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