Present-Day Clinical Trial Landscape
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Present-Day Clinical Trial Landscape

By Jim Kremidas, Executive director, Association of Clinical Research Professionals

Jim Kremidas, Executive director, Association of Clinical Research Professionals

It is one thing to recognize the potential benefits of a technology, but it’s another thing entirely to become comfortable enough to use it with any frequency.

That’s where we find many clinical trial professionals today.

Clearly, it’s important for vendors and other proponents of technology to help educate and inspire those who aren’t early adopters.

"Vendors and other developers of new technologies in the clinical trial space must also win over a sometimes-tough site constituency"

Evidence abounds. A 2017 survey of 466 sites worldwide from DrugDev found that, while many sponsors were excited about leveraging new technologies, they were flummoxed by several factors, including:

• The difficulty and/or time required for training on the tech (with 60 percent saying it is “sometimes,” “often,” or “all the time” a barrier)

• An app associated with the tech is too hard/not intuitive (55 percent said it was sometimes, often, or all the time a barrier)

• The tech is too time-consuming to use vs. paper/e-mail/fax (53 percent sometimes, often, or all the time a barrier)

On the positive side, it’s also worth noting that the “human factor” isn’t a significant hurdle–at least not yet. According to the survey, about two-thirds of responding sites reported their staffs were “rarely or never resistant to learning new technologies.”

However, we can squander user openness if we don’t quickly develop technologies that are user friendly. Vendors and other developers of new technologies in the clinical trial space must also win over a sometimes-tough site constituency.

In these early days of advanced technology usage, sponsors are looking for trusted site partners. Sites that resist could find their business operations threatened as more and more sponsors look to the sites that demonstrate they can leverage tech innovations for increased efficiency in studies.

For example, the adoption of mobile data collection, mobile visits, smartphones, and wearables means trial participants don’t always need to trek out to a site. The result? The preferred sites for more studies will be those with the flexibility to work with decentralized subject populations, and fewer overall sites will likely be needed for many studies.

Finally, let’s not let the promise of technology run amok. We can’t let it obstruct the fact that at their most basic level, clinical trials are about people.

In fact, good old-fashioned, in-patient contact remains far and away the most effective engagement tactic, according to 2018 survey of clinical research professionals from SCORR Marketing and Applied Clinical Trials.

In-person engagement was rated an 8.57 (on a 10-point scale), with phone contact at 7.45 and text messaging registering a 7.21. Interestingly, chat/instant messaging was last with a 5.37 rating, while companion apps posted 5.38.

Mobile health (mHealth) wearables received a decidedly mixed verdict: 43 percent, or a plurality of respondents, said they were unsure of their value. Nearly 25 percent outright said mHealth devices did not improve return on investment (ROI) in clinical trials.

“This uncertainty over whether technological innovations provide positive ROI may be impacted by a growing belief that innovations take too long to implement,” the survey report suggested.

In other words, users are ready to embrace technology if we provide solid evidence of its value, offer effective education to remove the fear factor from risk-averse professionals, and never forget that while technology is a valuable tool, it’s a moot point if we aren’t able to get people energized and onboard.

Together, if we can demonstrate value and ease of use, everyone will benefit from exciting new innovations, including patients, sites, sponsors, and contract research organizations.

Patients deserve no less.

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