Technological innovation in clinical trials could slow once again as the global health crisis eases and sponsors calculate their return on investment (ROI) for the innovations they adopted during the pandemic. Experts say remote monitoring, telemedicine and the increased use of decentralized trial approaches have proven their worth and are here to stay.

However, Ken Getz, director of the Tufts Center for the Study of Drug Development, says he worries “that when the necessity that was created out of a public health crisis goes away, you may see a highly risk-averse community of sponsor companies looking to ease off on the rate with which they adopted a lot of these approaches.”

“We opted to forego many things during the pandemic, like proof of ROI, which is normally a very common expectation for any new solution that’s applied to clinical trial activity,” Getz told CenterWatch Weekly. “But once we gather metrics that provide more insight into the investment required and a relative value of the return of that investment, some of these approaches may go away, or we will choose not to embrace them as fully as we did during the pandemic. There’s a financial ROI imperative that has to apply to these innovations in the future, moving forward.”

The adoption of innovation wasn’t exactly the industry’s strong suit before the pandemic. “It was abysmally slow,” Getz said. “In fact, some have argued that companies were stuck in a perpetual pilot mode, or proof-of-concept mode, and as a result the industry never fully embraced a lot of these compelling approaches that conceptually sound very promising” (CenterWatch Weekly, Aug. 3, 2020).

Some examples — such as the use of wearable devices, home nursing networks, and delivery of clinical and drug supplies to a patient’s home — were once all pilot programs that became standard practice to support trials during the pandemic. He added that the crisis presented a great opportunity to innovate, “given our growing reliance on patients as the primary source for their data, for real-world data and data that can be gleaned from wearable devices and patient health records.”

Before the pandemic hit, there was already widespread understanding within the industry that innovations could be leveraged to improve and augment clinical trials as long as they did not hit the bottom line too hard, says Dustin Caldwell, co-founder of OSM Cloud Research and former director of strategic development at Optimed Research. But after a “push on the gas” that made things like remote monitoring an essential part in helping trials to continue through the pandemic, Caldwell sees the industry eventually reverting to slow, incremental adoption of innovations.

“I don’t think we’re going to see anyone slamming on the brakes,” Caldwell told CenterWatch Weekly. “The pandemic forced us to look for innovations and acted as a sort of incubator for new ideas, and it gave sponsors an opportunity to get out of the limited pilot space and try them a bit more broadly. We’ll continue to see adoption in the areas where they worked. If we’re still seeing good compliance rates, if CRAs are still able to identify problems and there’s a good transparent system in place, I think we’ll see more and more CROs and sponsors okay with utilizing these types of approaches.”

Caldwell said sponsors are under pressure on two fronts: from shareholders leery of the cost of innovation, and from their responsibility to the public to make sure clinical trials are conducted safely and ethically. “You’ve got pressure from both sides to be very cautious about innovating within the space,” he said, adding that the pace for innovation in a post-pandemic world “is really going to be set by how much risk sponsors and CROs are going to take. The hope is when we have enough people take the initiative to demonstrate the efficacy of these technologies and show how they can augment and improve the types of data that we’re collecting from clinical trials, it will help to make the case that technology has more of a place in these trials.”

That said, Caldwell said it was his experience — and, anecdotally, in speaking with other sites — that there seemed to be greater success with technological solutions chosen by sites, especially those that “are ready and willing to adopt technologies, understand the value that they bring and are invested in their success. Conversely, foisting a tech platform onto a site for a purpose of a single study is not always successful and many sites can even be resentful of the disruption to their workflows.”

Many sites, especially those that remained open for enrollment during the pandemic, appear more than capable. “The sites that remained open for enrollment were the most experienced investigative sites and they were the most familiar with the shift to remote and virtual approaches,” Getz said, adding that some had piloted innovations like telemedicine.

According to an annual survey of the industry released last month by Florence Healthcare, a technology vendor that provides technology solutions to sites, 68 percent of 75 respondents who opined about risks in 2021 said their primary concern is costs associated with technology adoption. The survey received 241 responses overall, with CROs making up 17 percent of respondents, followed by academic medical centers (15 percent), independent sites (15 percent), pharma (12 percent), hospitals and hospital systems (9 percent), biotech (8 percent), cancer centers (5 percent), site networks (4 percent) and medical device manufacturers (3 percent). Respondents who didn’t fit into any of these categories and elected to be listed as “other” totaled 12 percent. Most respondents were in upper-level management.

During a December webinar to discuss the survey, Marc Leighton, Florence’s vice president of product, said sites will probably have a bigger role to play in the budgeting process in a post-pandemic world. He said sites should treat the process as an investment and that in budget talks “it’s really helpful just to juxtapose your current state, the technology and the vendor you want to partner with, and what the future state will be.

“You want to be very clear with your assumptions,” Leighton added. “Don’t go at it alone, partner with a prospective vendor — they can help craft a message, and there’s strength in numbers to the budgeting process.”

Sponsors need to ask feasibility questions when they start picking the sites they want to partner with for a clinical trial, according to Andrea Bastek, director of innovation at Florence. “This year has made it clear that digital collaboration is essential for everyone’s success,” she said, adding that sponsors need to ask sites questions about their platforms and whether they will be able to access data from sites easily. Sites know sponsors want faster startup times, clean data and easy access, “so having a system that allows you to offer that to a sponsor is really valuable.”

Blake Adams, vice president for marketing at Florence, opined that the emergence of decentralized trials has led to a shift in roles between sponsors and sites. “What we’ve found is if sites have taken the first step toward digitization, if the site has invested in site-based technology, the sponsor will integrate with that technology because they see the benefits of not disrupting site workflows. For others, [sponsors] roll out that technology in a site-friendly way. It all has to focus on solving site workflows — whether it’s the sponsor or the site that starts the journey.”

Caldwell said it was hard for sites to have a voice in making innovation decisions. “It would be good if sites had an opportunity to find solutions that work for them. Widespread adoption of these solutions could force the industry toward a more technologically aggressive mode, but there isn’t a lot of power to affect change at that level. At the end of the day, it’s going to come down to costs and risk.”

But Ken Lownie, head of North American operations for Agatha, another technology vendor, said sponsors and CROs will likely continue to call the shots as far as software is concerned. “In our experience, it’s mostly the sponsors and CROs who pay for software and extend its use to the sites for their study,” Lownie told CenterWatch Weekly. “The sponsors ultimately have the leverage in our industry — they have the money and they largely can dictate what software will be used on clinical studies. It’s the way the economics and dynamics have driven things.”

Lownie also warned against sites forestalling or reconsidering the adoption of new systems on fears that such adoption could put them in a noncompliance situation with the FDA, European Medicines Agency and other regulators. Lownie, Getz and Caldwell each emphasized FDA’s support for remote monitoring and called noncompliance fears unfounded.

“I am very confident that the remote monitoring practices that were accelerated during the crisis will not be looked askance at or will fall backward, and that is from direct conversations with FDA,” Lownie said. “They’ve been very clear in their guidance that remote monitoring is a very good thing, not just for COVID-19. It saves time and it saves money. I find them completely supportive.”

The Florence survey predicted stronger and more significant collaboration between sites and sponsors in solving challenges by 2023, with 90 percent of sponsors and 62 percent of sites believing patient source data collection will be mostly automated by that year. Additionally, 80 percent of sponsors and sites expect consent, study startup, recruitment and monitoring will mostly be accomplished with technology by 2023.

“I certainly admire that very aspirational projection,” Getz said of the survey’s prediction. “The trends suggest that we’re moving in that direction. Whether it occurs in that arbitrary year or not is hard to tell. It may not unfold as quickly as is forecasted.”