Industry’s Approaches to Site Training Are Evolving for the Better, Experts Say
The switch to virtual site training during the past year has not only saved time and travel, it’s allowed staff to have access to quick on-demand reference materials from their training they can refer to as they encounter real-world situations.
Because the training and reference material is in the cloud, a quick visit guide, for example, can be pulled up by a coordinator on a tablet while they’re with a patient.
“Before, I’d say 50 percent never even went back in and looked at [the training material.] It’s where they go now,” says Ericka Atkinson, vice president of operations at WCG Trifecta. “You’d have like an hour-and-a-half-long protocol presentation — now they’re 20 minutes. We’re starting to see those quick reference tools used, because I believe sponsors are realizing that these people are working on multiple trials, and it’s hard to remember everything that you trained on two months prior to seeing a patient.”
Such platforms also cut down on redundant training for sites, especially those that are conducting multiple studies of the same compound. For example, instead of having to take GCP training for each study, users are exempted as long as they have an active GCP certificate, Atkinson said. And if the trial involves the same compound, they don’t have to go through the compound overview more than once because they already took it on the previous study, she added.
“It is saving sites so much time,” she said. “On average, 90 percent of our users are active on more than three studies within [our platform]. If you can save sites that much time getting up to speed training, that’s more time with patients.”
The system also gathers information on knowledge retention using assessments that are done in stages. For instance, in the case of raters who are assessing disease state in a trial, the platform tests users on their consistency of rating and disease assessment, providing sponsors with a picture of rater reliability and consistency.
“Sometimes that matters on a trial and sometimes it doesn’t, but it allows the sponsor to see how sites are performing in the real world,” Atkinson said.
In addition, the company’s platform allows site staff to view the trial’s investigator meeting on demand in case not everyone was able to attend, turning it into an asset for the duration of the trial where in the past it was a one-time event, she said.
“They’re also pushing amendments through the on-demand system to ensure they have training documentation in the event of an audit … but then what we’re seeing is we’re doing a lot of web-based meetings for Q&A, for site engagement, refreshers, and sites are talking. Sites are speaking up,” she said.
The need for the greater adoption of better site training methods is apparent in the compliance issues that still remain, said Beth Harper, chief learning officer of Pro-ficiency, a firm that offers remote good clinical practice (GCP) and informed consent simulation training for sites. The top FDA clinical investigator inspection finding has historically been, and continues to be, investigators failing to follow their investigational plans, she noted.
While some FDA findings stem from issues that are out of sites’ hands, such as inclement weather barring a participant from coming to the site on schedule, many deviations that get written up are avoidable, according to Harper, who also serves as acting workforce innovation officer for the Association of Clinical Research Professionals (ACRP).
“A lot of the deviations are things that are within the control of the sites, they just didn’t understand the protocol or they made a mistake, and so we have to just keep asking, if our current training was so good, we should have zero deviations that are preventable,” Harper told CenterWatch Weekly.
In Harper’s view, sponsors should take a step back and consider whether they view site training as a way to mitigate risk or as a compliance box to tick off and be done with. Adopting a better training strategy from the beginning can help prevent mistakes in the first place, she said, instead of having a CRA come in and find issues.
Pro-ficiency’s simulation platform, while it’s done remotely, views site training as an opportunity to not just provide information and knowledge checks, but to verify that trainees can apply the knowledge in real-life situations and take the appropriate actions when things go wrong. Using the platform, sites go through simulations of the most critical things likely to go awry in their trials and try to prevent the deviations from occurring, Harper explained.
“Think of simulation for pilots. We don’t teach pilots how to fly planes just by reading a thousand-page manual. They have to spend hours in the simulator, simulating, oh my gosh, a bird flew into the engine, what do you do?” she said.
“That’s the idea of what we do. We have a platform and we go through a process. It’s elearning in the sense each individual does it remotely, but it’s not a typical elearning module that you’re just providing information and some knowledge checks. We’re actually testing if people can apply the knowledge.”
Elearning modules grew to become a popular modality for training sites over the years, but they were “probably overused and not that effective” as they caught on, she noted. Similarly, Zoom meetings and recorded webinars have seen a much greater use as a result of the pandemic, but the same tired compliance problems persist, warranting a deeper look at what’s behind them.
Those remote technologies pose their own sets of problems for site training. Elearning is often an unpleasant, loathed experience for investigators and study coordinators who need to address things that go wrong in the trial, not memorize stuff for hours, Harper said.
“They would have these clocks, they would do something, like if you weren’t paying attention, you had to click a button … [or] you’d have to start over. They were kind of monitoring you like big brother,” she said. “Some of them might have some quiz questions in there, but … we’re not trying to teach them to be good test takers — we know that, they went to medical school and so forth. We’re trying to make sure they can apply what’s really unique about my study compared to some other studies.”
Zoom meetings and recorded webinars can also bore trainees, as they don’t really engage site staff and can take hours to get through while failing to offer interactive opportunities, such as asking questions, the same way as face-to-face meetings, she said.
Harper believes that sponsors are moving, albeit slowly, toward the risk mitigation mindset and realizing that the potential for noncompliance should be considered a key risk that can be managed with a more creative or strategic approach to site training.
“If we expect a lot of deviations in certain areas or we have something really complex, we need to make sure that we actually have a quality way to teach the sites how to do those complex things, to teach the CRAs so they understand what the sites are going to go through, and they can monitor or help coach them more effectively,” she said.
Additionally, those gunning to be sponsors of choice are starting to see strong site training strategies as ways to stand out to sites they’re competing for. Sponsors that employ more engaging ways of training their sites instead of, for example, an eight-hour recorded webinar, may attract more sites to work on their studies, Harper noted.
While there may still be work to be done in opening minds across the board, there’s been great evolution in how sponsors think about site training and what sites actually experience.
“Some are slower adopters than others, but as a whole I’d say the industry is so much more mindful about what they’re putting out vs. what they used to put out. If you saw some of the old content … it was terrible. It’s not terrible anymore. It’s pretty darn mindful,” Atkinson said.