As the pandemic-era lure of decentralized trials (DCT) waned last year and traditional trials reasserted themselves, sites considering sponsors in 2023 are placing critical importance on sponsors’ willingness to accept and integrate site-picked technology.

According to Florence Healthcare’s fourth annual State of Clinical Trial Site Enablement Technology survey published this month, 36 percent of site respondents named this as the most critical factor for them when selecting sponsors, emphasizing the importance of technological compatibility for sites.

From the sponsor perspective, they now place great importance on how sites perceive them, too. In total, 65 percent of sponsor survey participants feel it’s very important to be viewed as a “sponsor of choice” amongst sites, a huge uptick from the meager 14 percent observed just a few years back in 2019. Overall, 79 percent of respondents anticipate that securing sites’ favor will be of the utmost importance over the next three years.

This change in priorities, the 455-participant survey report says, has caused sponsors to rethink past approaches of imposing their own technology and platforms on sites, which have increasingly modernized and leveraged new technology.

But even still, Florence’s report highlighted that sponsors rank willingness to accept their technology as the highest technology-related criteria in site selection.

“At first blush, it looks like there’s a stalemate, right?” remarked Florence CEO Ryan Jones during Wednesday’s webinar on the company’s 2023 State of Clinical Trial Technology Report, highlighting that sites “are insisting to use their own technology and sponsors are insisting to use theirs.”

But Jones contended that sites “have more power in the research value chain than ever before” due to factors like increasing protocol complexity, such as those seen in precision medicine trials, and the ability to determine participant inclusion and exclusion criteria, which also encompasses diversity considerations. To Jones, this means that sites will ultimately get to write the rules when it comes to technology adoption.

Likewise, Archana Sah, founder and CEO of AS Pharma Advisors, tells CenterWatch Weekly that sponsors should allow sites to use their technology and not force sponsor-provided technology on them. Sponsors must also “invest in training sites and select vendors that offer platform solutions as opposed to point solutions which cause complexity for sites and patients,” she says.

“What often won’t work is study-specific technology that involves yet another training, individual password and login, and another new workflow,” concurred Mary Costello, head of site and investigator network at Medable, opining that these sorts of “technology offerings often can add burden to overwhelmed site staff.”

So how does a company, institution, or CRO become a sponsor of choice in the eyes of sites? In Florence’s survey, sites picked six main criteria, ranked in order:

• The sponsor accepts site-owned software such as electronic investigator site files (eISFs);
• the sponsor uses/provides best-in-class site enablement technology which prioritizes site needs;
• The sponsor uses/provides technology for remote document exchange;
• The sponsor trains clinical research associates to use eISF/eregulatory platforms;
• The sponsor supports source capture of clinical trial data with technology; and
• The sponsor communicates through purpose-built technology.

For their part, says the report, 78 percent of sponsors said they aim to provide their sites with eISF software by the end of the year, while 63 percent of sponsors have deployed them this year-to-date, with both numbers a far cry from just 11 percent of sponsors that reported providing eISFs to study sites in 2021. The report also notes that an increasing number of sites are choosing to develop their own eISF platform rather than waiting for one from a sponsor; in 2022, 38 percent of sites owned their own eISF, but this figure has jumped to 50 percent in 2023.

As for technology itself, 62 percent of site respondents said automating repetitive tasks was the most important factor in technology selection, not only due to the number of manual processes in trials but also because any sponsor-introduced technology that is not properly integrated may create additional repetitive work.

Importantly, says Costello, any technology “that helps sites work more efficiently or assists with data quality and error reduction without the expense of added time will lead to sites earning more study opportunities.”

“Technology that can help integrate workflows, efficiently store regulatory documents, reduce friction, redundancy and error, and help identify or onboard participants faster position sites favorably and pays off over time,” she said.

And Florence’s report says sites should know the value they bring to the trials ecosystem and stand firm against sponsor software that disrupts workflows, while taking advantage of sponsor-deployed site enablement software when it addresses their needs, to save money and test drive software before investing in it themselves.

In addition, the report advises that sites require software vendors to demonstrate an expected return on investment of new solutions and conduct an annual business review to ensure these objectives are being met. But sites should explore the feasibility of solutions they control, continues the report, and integrate those with existing workflows, “as these will likely be the next wave of solutions sought by sponsors.”

Christian Djurhuus, owner of Djurhuus Consulting, which specializes in digitizing the clinical development process, advises that sponsors simply be upfront about the benefits and risks of any new technology. As for sites, Djurhuus advises that intraoperatively digitalizing ISFs will make sites far more attractive to sponsors, telling CenterWatch Weekly that most “sites have their own processes and systems, but these prevent efficiencies towards the sponsors.”

Djurhuus believes sites would find great value in digitizing delegation of authority logs and “making it possible for sponsors to link access rights to the delegated individuals.” In his mind, this would enable remote monitoring to a significantly greater degree and allow for increased efficiencies in risk-based quality management.

“Teething issues exist with all new technologies — it’s the nature of an agile development process,” Djurhuus concluded.