By Allison Proffitt

February 18, 2019 | As part of its mission to gather patient insights to optimize clinical trials, HealthiVibe has formed a Digital Patient Experience (PX) Lab, a formalized process of testing wearables, mobile apps, and virtual platforms used in clinical trials.

All types of different devices are being used in clinical trials, says Valerie Powell, Vice President of Research Services, who will head the Lab. And while they are thoroughly tested by the device and software developers, the testing is never specific to the patient populations using the device in a clinical trial.

“Just because a certain type of tracking device works really well in healthy athletes doesn’t mean it’s going to work really well in a stage 4 cancer patient who’s going through some really brutal chemotherapy,” Powell tells Clinical Research News.

HealthiVibe is addressing that with custom device and platform testing on patient groups that match the inclusion/exclusion criteria set in the trial, both in a digital experience lab and in the patient’s home, workplace, or wherever the device will be used.

Pharma sponsors can come to HealthiVibe either with a particular device in mind to test and optimize about six months to a year before trial recruitment begins. Or a company may be looking for help choosing the right device or application for a trial. “In that case, it can be very early on,” Abbe Steel, CEO of HealthiVibe, says. “It can be before they even issue an RFP to the tech vendors.”

In the second scenario, Steel says HealthiVibe’s lab is, “almost a digital playground, a tech playground. We’ll put 10 different Bluetooth inhalers on a table for an upcoming asthma study and let the patient touch and feel and play with and naturally help the sponsor select which one they should contract with.”

Getting the devices to test can be challenging. Sometimes HealthiVibe buys consumer products to test. Some sponsors have requested candidate devices to be shared with HealthiVibe for testing. Some vendors are happy to share; others are not.

Getting patients to participate in testing has proven easier. “It’s really important that these [products] are tested first with the target patient in mind,” Powell says. Thanks to market research databases, patient advocacy groups, physician referrals and more, HealthiVibe has been able to match groups to testing criteria.

HealthiVibe’s “ask” is also easier, Steel admits, than patient recruitment for clinical trials. Testing devices or platforms is a relatively short-term process—sometimes a few hours, sometimes a few weeks—and requires no medications and no medical tests. “We don’t require that for our work. We’re trying to find a surrogate, if you will, for a patient. Oftentimes it’s almost identical, but we don’t actually do lab work,” Steel explains.

In every case, HealthiVibes strives to be device agnostic, committed to making recommendations based only on a device’s fit for a particular patient population. “We truly want to be there to help figure out what would work best for patients,” Steel says.

Even when the team has experience in an indication—as Powell does with oncology—HealthiVibe is looking for very specific usage data. “I know this particular wearable works really well in a younger breast cancer population. That doesn’t mean it’s going to work really well for an older prostate cancer population,” Powell says. “We really do need to get that experience with a very particular population for a clinical trial to know it’s definitely going to work for those people.”

Finding severely ill patients can be harder, but in those cases it’s all the more important that HealthiVibe’s device and platform testing works with representative patients.

“We just did a lung cancer [study] in December,” Steel recalls. “We really needed to find people that were at the same level of severity and illness. And it was hard. These are really sick patients that the client will be having in their study. If we had found people with a milder condition, they may have said they had an easier experience… than somebody who is really ill and can’t even get out of bed.”

In the end, HealthiVibe worked with a patient community and a market research database and was able to find appropriate patients who participated in a two-hour, paid advisory board meeting.

Investments in Research

Upwards of 40% of the more than 150 projects HealthiVibe has done on behalf of pharma over the past years has had a key technology component, says Steel. “We’ve always been doing this in one way or another, but we’re having more formal processes and structured methodology,” Steel explains. “We’re also building on it.”

The launch of the Digital Patient Experience Lab represents a bigger investment in ethnographic research, biometric measurements, and home and in-person observations.

HealthiVibe partners with state-of-the-art digital usability facilities across the globe that offer eye tracking software and devices cameras in the lab to track how patients are interacting with websites. HealthiVibe can collect biometric data to measure heart rate and nonverbal cues: “Did they smile? Did they frown? Did they seem confused? All these technologies that we have within the lab [help] to really figure out what would work best,” Steel says.

These technical capabilities are not new to market research, Steel says. “What makes what we’re doing different is we bring [patient testers] into this setting and we sit down with them. We interview them. We talk to them about the trial and the visit schedule and the procedures and how they learn and hear about information. What they’d think if they saw a recruitment ad, and what they need for study visit reminders. All of that is weaved in with the technology testing to really figure out the entire study experience,” Steel says.

“The value that we bring is that we understand how clinical trials are run. We understand how these things are used.”

Editor’s Note: HealthiVibe is exhibiting at this week’s Summit for Clinical Ops Executives in Orlando. You can learn more at booth #512