Many clinical trial researchers don’t know what patients want — primarily because they never ask.

The industry typically does a great job gathering clinical data and endpoints, says Alicia Staley, vice president for patient engagement for Medidata, a New York City-based company focused on the digital transformation of life sciences, with a focus on clinical trials. But if asked whether patients are having a positive experience in the trial, those responsible for running the trial might draw a blank.

“We just haven't done the best job of understanding the true patient experience,” she says.

That may soon change. The migration to decentralized clinical trials (DCTs) is helping to understand where the gaps are to better gauge and improve the patient experience, which can be highly variable depending on the therapeutic area.

“In the next 18 to 24 months, there will be a doubling down on what the patient experience really means,” Staley says. “Are patients happy? Are they getting the right tools? And are the tools that we're putting in front of them truly the best options?”

Because decentralization is a platform technology, it's well-suited for at-scale data survey collection, says Dr. Irfan Khan, CEO of Circuit Clinical, a Buffalo, NY-based integrated research organization.

As the industry shifts to the increased use of DCTs, there are fresh opportunities to make these long-needed changes that encourage broader participation and a more patient-centric research model. 

Driving improvement

Collecting patient data isn’t always easy, but it can pay off. For example, it can help clinical trials make improvements in real time, Khan says.

“One of the reasons to consider a DCT approach is to improve the patient experience of the trial and trial performance, which is obviously very valuable,” Khan says.

It’s estimated that as many as one-quarter of clinical trial patients drop out. In some niche therapeutic areas that percentage may be even higher, Khan says. In half of the drop-out cases, it’s not clear why the patient left, he says. Questions such as was it something related to the trial or not need to be asked more frequently and with clear intent. A better understanding of patient motivations might not only reveal these reasons, but also allow researchers to intervene to improve retention.

Measuring and improving the patient experience could also bolster recruitment efforts, Staley says.

“I think there is an opportunity to elevate the game for everybody,” she says. “It may translate to better numbers, better retention, better recruitment efforts, and trials that actually can get 100% filled.”

The advent of public, Yelp-style, clinical trial reviews is another tool that could help encourage trial participation, Khan says. Circuit Clinical’s website, TrialJourney, aims to help people find clinical trials and, according to the company, is the first that allows patients to submit public reviews of their trial experience. The goal is to help guide decision-making and to make trials feel more accessible by showing the thoughts of real people who have taken part.

“If you were a patient participating in a decentralized trial and were able to share your voice more broadly to help the next patient choose a clinical trial this would really be transformational,” Khan says.

But public reviews also need to be framed properly to ensure a fair exchange, and carefully vetted to ensure authenticity.

“There has to be enough security that people feel comfortable sharing parts of their identity,” Khan says. “And then there has to be a process to validate that it’s a legitimate review.”

Measuring the patient experience

Many decentralized clinical trials will need to have a process put in place to measure patient engagement and satisfaction from the ground up. But where to begin can be challenging.

“I think there's a lot that we can borrow from other industries,” Staley says. DCTs can build patient-monitoring right into their current processes. In some ways, it’s a natural fit.  

“The concept of decentralization is great in that regard, because through the use of technology, patients can stay involved in a clinical trial, without actually having to physically go to the site,” she says. “From there, we should be able to layer in appropriate touch points in the trial to ask patients very important questions about their experience.” For example, what is it like to participate in a trial? Or, what keeps participants motivated?

“It’s not just questions such as, ‘Is this medication working?’” Staley says. Rather, she says trial designers should ask: How's your experience? Do you feel comfortable? Do you feel safe? Do you feel like you can trust the people who you're relying on in the clinical trial?

“Give patients an opportunity to express themselves when it comes to the mechanisms that facilitate the trial,” Staley says.

There may be several challenges to navigate in adopting this process. For example, if a DCT is using a web-enabled form or electronic patient survey process, it’s important to ensure that the platform is secure and protects patient privacy.

Another challenge is designing the survey form and process. Khan says survey design should be a priority, because questions need to be culturally and linguistically appropriate.

Looking ahead

Like any change, this new focus on the patient experience will require a culture shift within organizations, Staley says. But it’s also a chance to help improve the next generation of clinical trials for those who participate.

“This is an opportunity for the industry to say, ‘We've got an opportunity here. We've got patients who are ready, willing and able to talk to us about what we can do to make it better,’” she says.