By Allison Proffitt

March 15, 2018 | The Clinical Trials Transformation Initiative (CTTI) conducted a survey of potential research participants as part of its Mobile Clinical Trials program. Hassan Kadhim, a business consultant for clinical operations at Boehringer Ingelheim and a member of CTTI, presented the findings of the Stakeholders survey at the Summit for Clinical Ops Executives or SCOPE* last month.

One year ago, Kadhim wrote in Clinical Informatics News: “Although it is clear in my mind that the remote trial concept is the way of the future for conducting clinical research for the pharmaceutical industry, we are not yet fully ready to seamlessly adopt this concept.” The results of the CTTI survey, though, show that the industry is making progress. Trial participants are enthusiastic about mobile trials, and challenges for sites and investigators are being better defined and addressed.

The industry is moving forward.

Participants’ Perspective

CTTI surveyed potential research participants to understand patients’ interest in, preferences for, and concerns with using mobile technology in clinical research. CTTI recruited participants with ResearchMatch and a cohort of 193 respondents answered a 92-question survey.

Most of the respondents were women, and the average age was 60 years old. Most reported being in good to very good overall health, though 73% had been diagnosed with something within the past five years, Kadhim pointed out. 72% had never participated in a clinical trial. And while 87% use a smartphone daily, 56% had never used a fitness monitor.

The study presented potential trial participants with two options: a traditional trial with 13 site visits in a year and a battery of tests conducted at the sites, or a “mobile trial” with three site visits in a year, and most data collected via a wrist-worn health monitor and smart phone.

Half the group heard about the traditional trial first, the other half heard about the mobile trial first. After each trial was explained, participants were asked if they’d be willing to participate. 80% of participants said they would take part in the mobile trial as outlined; only 51% agreed that they would take part in the traditional trial. When given the option to choose the trial of their choice, 76% said they would prefer the mobile trial.

Those who preferred the mobile trial liked the fewer clinic visits. They felt the health monitoring device would gather more accurate data and would let them track their own health. On the other hand, patients who preferred the traditional trial were wary of burdensome mobile technology, and preferred more direct interaction with a physician.

Of the various types of monitoring devices, participants were most comfortable with wrist-worn devices, and least comfortable with ingestible devices, though more than 60% said they would be willing to use such devices. And in general, survey respondents were willing to wear or use a device for as long as needed. More than 50% of respondents said they would be willing to wear or use any of the devices—from wrist-worn monitors to smart phone apps to ingestible devices—daily for as long as the trial lasted.

But convenience ranked among participants’ highest priorities for a device: easy to learn, simple to use, physically comfortable, and with available tech support. And, of course, tech support is often needed. Most participants—79%—said they would want to contact the clinical trial staff if a device stopped working, and 57% said they preferred to be initially trained on a new mobile technology in person by site staff. Slightly more than half of participants in the survey expressed a preference for provisioned devices over their own; one third didn’t care. Only 13% preferred a bring-your-own-device or BYOD trial. One major concern for patients using their own device Kadhim highlighted: that their own personal data minutes not be used for the trial.

In terms of security, about half of the participants said they would not take part in a mobile trial if they were uncertain of confidentiality, and 78% wanted password protection on a device. But a far greater percentage—98%—said it was important that they see their own data. Participants wanted feedback, either via a website (67%), on the device itself (52%), or in a meeting with trial staff (31%).

Investigators Weigh In

But CTTI didn’t just survey would-be trial participants, Kadhim expained. The team also conducted qualitative, semi-structured phone interviews with 12 investigators who had been part of both mobile and traditional trials. In the investigators’ views, the burden on site staff is a major disadvantage for mobile trials. They cited operational challenges for site staff, and said that real-time data creates new expectations for site staff. Staff bear the burden of managing and maintaining the devices, troubleshooting with trial participants, and training new participants on the device. (These opinions were echoed during the sites panel at SCOPE as well. Read more at “Pain Points for Clinical Trials Sites Abound In Systems And Devices”.)

The investigators in the CTTI survey didn’t rule out real advantages to a mobile trial, though. The felt that mobile trials could reach more participants, improve participant adherence to protocol with reminders, decrease the participant burden, and improve the quality of the study.

But they also expressed concern that a mobile trial doesn’t enable the same rapport with patients that a traditional trial does, and raised concerns about study population selection bias because of wireless access or technological literacy. They also warned that patient behavior can change when using a monitoring device.

Successful mobile trials should involve patients early on and carefully consider how and why devices are used. Clinical trials should not be designed around a device, investigators said. Ensure that the burden of device use is truly necessary to the research. Then devices should be thoroughly tested under the real-world conditions of the trial.

“I think that if you have a participant that is, for whatever reason, frustrated with the device or having technical problems with the device, that person may actually become less engaged with the study or may even drop out of the study,” warned one investigator that Kadhim quoted.

The investigators surveyed also reported some of their own missteps in past digital or mobile trials. Many investigators said they had budgeted poorly for their earliest mobile trials. They underestimated staff time for troubleshooting and participant support and training. The hardware costs of devices were “an afterthought.” One investigator called his first mobile trial, “a total learning experience for us”. 

Their advice for investigators of future mobile trials included careful contracting, and they warned that the contracting process may be longer than normal. There should be a clear delineation of responsibilities for all parties, particularly related to devices and technology problems. Have policies to address device loss or malfunction and data loss, the surveyed investigators advised. Contracts should include line items for technology-related costs and increased time and effort for the sites. Tech support should be easily accessible and sufficient throughout the life of the trial. Expect extra staff time and funding, especially early on, investigators warned, and work to streamline and centralized the processes for scalability.

* The Summit for Clinical Ops Executives, SCOPE. February 12-15, 2018; Orlando, Fla. SCOPE is produced by Cambridge Healthtech Institute, the parent company of Clinical Informatics News.