AI-Assisted, Decentralized Clinical Trials: Trial Sites Will Always be Crucial to Good Research

By Ed Ikeguchi

It may seem controversial for the CEO of a remote technology company in the clinical trials space to say that we can’t do what we do without clinical study sites. But I think it’s true. Despite the explosion in innovation we’ve seen over the last decade or so, with AI-assisted technologies that allow us to collect data around-the-clock from patients wherever they are, the role of study sites remains crucial to finishing a study with the best possible data.

Recently there’s been a lot of talk in our industry about virtual trials or decentralized trials. The desire by sponsors to do as much as possible without the need for patients to visit a clinic has been catalyzed by the COVID-19 pandemic and its off-and-on stay-at-home restrictions, high hospital census rates, and the patients themselves wishing to be as cautious as possible. It hasn’t been uncommon to hear the term “siteless” trials pop up. Of course, the concept is attractive – in theory it could be a money saver and possibly a time-saver. But it fails to consider just how difficult and critical patient engagement is to a study’s success.

The Patient Needs a Champion

There has been a historical tendency in clinical research to view patients as numbers. We’ve made strides in recent years to take more patient-centric approaches to building and executing trials, but the concept of siteless trials seems to me a step backward in this regard.

People want to talk to people. It’s one thing to give patients a support phone number or email where they can ask questions of people they’ve never met, but it is quite another for them to know their study clinicians. Patients want to know that their doctors are full participants in their care plan, fully aware of their status and needs and ready and willing to lend their support. Whether it be regular clinical care or research, patients view their doctor as their healthcare quarterback. They’re never going to have that feeling for a pharmaceutical company, CRO or some impersonal intermediary that checks in on them periodically before delivering their trial medication.

The connection between the study clinician and the patient is a strong tether and as the study progresses and they get to know each other even better, that tether grows stronger, building trust. For a patient participating in a siteless trial – no such tether exists, which can make them feel isolated. This makes it easy for patients to drop out of studies.

A Question of Training

There are so many great technologies being deployed for remote patient monitoring and engagement right now. Many of them are remarkably intuitive and easy to use. Even so, what happens when patients are completely on their own to get trained on these technologies and applications? Before they get to this point, how can we be sure they fully understand the study itself and what’s expected of them? Do they know what a placebo is, and do they comprehend and buy-into the value of their participation in the study even if they are in the placebo group? It’s difficult for tech demos and walkthroughs to cover all the bases necessary to keep patients active and motivated.

This is where in-person interactions with study clinicians is so important. Every patient is different, and the study team can assess and understand what levels of training and support each patient will require to be successful. They can build strategies to keep patients motivated and the relationship they build with their patients creates a tangible sense of accountability. They become a team, and they don’t want to let each other down.

Technology and People Working Together

To run an optimized, efficient virtual trial, I believe we need to employ a hybrid model that keeps clinical trial sites as the focal point of studies while employing AI-assisted technologies that complement what sites do and allows them to perform their critical work in a virtual environment. This kind of technology can reduce much of the site burden related to patient interviews and basic data collection. This allows clinicians to  give more focus to providing custom-tailored support to  patients that need it and less proactive outreach to patients who don’t need as much oversight. They can spend more time with data assessments and analysis and less time following up with patients to see, for example, if they’re taking their medications. The technology will have already told them this.

Patients in this model receive the best of both worlds. They are enabled by remote technology to be as independent as they want to be. At the same time, they know their site clinician is there for them when they have questions or if they just need to talk about their care.

The ultimate result is more engaged patients and more efficient sites. Add those two together, you’re likely to have quicker trials and better data which, after all, is what we’re all trying to accomplish whether we’re running Virtual Trials or traditional, multi-site studies.

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