Don’t ‘Overengineer’ Trials with Technology, Pharma Execs Say
Sites and sponsors have shown interest in permanently adopting technologies used during the pandemic to make trials more virtual and accessible to patients, but sponsors must be cognizant of the burdens such solutions can impose on sites and avoid using technology that would bog them down.
Andy Lee, senior vice president and head of global clinical trial operations at Merck, believes that sponsors need to listen closely to sites to understand what technology makes their jobs easier and what will have the opposite effect.
Sites “are not ready to industrialize and do this across the board, so we’ve had to use it selectively,” Lee said during a session at the DIA 2021 Global Annual Meeting. “It is double the resource and double the burden on the site, at least double. It’s a huge burden on the site using these new technologies and it is extremely costly and labor-intensive. It’s not free, it’s not cheap, and it’s not without burden.”
From Lee’s point of view, caution needs to be taken not to “overengineer” trials with technology, which can actually end up being “an inhibitory component,” he said. In addition, telehealth technology introduces privacy concerns that need to be taken into account.
“You see all sorts of things … and you don’t know who’s on the receiving end. There’s a huge privacy issue with that,” he said. “The technology is there … but we have to respect privacy and the ways we’re going to adapt this technology.”
It’s important to be aware of the complexities new approaches can add to a trial, even if the approaches appear advantageous. Home nursing, for example, offers many benefits in principle, but the data that are collected from patients in their homes has to find its way into the trial database, a component that, at present, can lead to difficulties.
“Right now, unless you’ve got a tablet that can actually collect that data with a person who’s on the [Form] 1572 from the site and everything, it’s complex. There’s a handoff of how that data gets from a notepad into the source documents and all of the rest,” he said.
Prior to the pandemic, sites were already overwhelmed with multiple passwords and portals they needed to enter, an issue that can be worsened by the addition of new technology to a trial, according to Sandy Smith, WCG’s senior vice president of clinical solutions and strategic partnerships.
But sites are not deterred from the adoption of new technology as long as they can share their perspectives with sponsors and CROs and work on longer-term solutions with them. A recent WCG roundtable of site executives revealed that sites are worried about reverting to prepandemic approaches, she said.
Liz Rogers, vice president and head of global site and study operations at Pfizer, shared the sentiment that sponsors need to work hard to communicate with sites to determine what they need and don’t need.
“There’s much more of a requirement on us as an industry to work together. There’s one thing, we need to be flexible, we need to adapt to what sites need, but we need to be smarter and work more together as an industry and work on platforms that help reduce that burden on sites because we’re all using the same type of tool,” she said. “The Shared Investigator Platform (SIP) is a great example of that type of platform, where we come together as key companies in the industry and we work together on a solution that we can work with sites on.”
Linda Sullivan, executive director of WCG’s Metrics Champion Consortium, said the issue comprises not just telehealth technology, but artificial intelligence (AI) and automated solutions and technology in general. In her mind, more conversation on the topic is essential so that sites’ voices are heard in the midst of a “bombarding” of technology.
“More communication is needed between sites and sponsors. It’s not a secret that sites are very frustrated with all of the different technology they have to be using in trials. It’s a big problem,” she said. “Outside of [AI and automation] … we’re bombarding sites with multiple technologies to have to use.”
Both sites and sponsors can take action to strengthen communication, said Brandon Graham, director of digital and decentralized solutions at PPD. For example, sponsors should be identifying key stakeholders at the site level to be present in discussions on the use of automation technology in trials, while sites should not be shy about describing the challenges they go through, he advised.
Even older, well-established technology can be overwhelming to sites, according to Saeeduddin Ahmed, a psychiatry, neuroscience, medical affairs and drug development consultant, who believes adding technology to trials will continue to be a much-discussed topic as time goes on.
“I was at a site not too long ago before the pandemic started, and they showed me just how many devices they have from different companies to measure EKGs,” he said. “It was half a room of different EKG devices because they have different ones from different sponsors. This is going to be an ongoing conversation in the upcoming years.”
Sondra Pepe, associate vice president of product management at ArisGlobal, noted that sponsors and CROs, in the current landscape, are not very informed about what technology sites are already using, which can lead to duplicate solutions. “Understand what your sites are already using. There’s no such thing as overcommunication,” she said.