Virtual training for clinical trial teams may have existed for years, but it has gained significant attention during the COVID-19 pandemic. Experts expect the popularity of this kind of training to increase, even after COVID-19 restrictions are relaxed.
WCG, a provider of regulatory and ethical review for human research, held a webinar in February to discuss the details and benefits of virtual site training. The webinar, “Virtual Site Training in Clinical Trials: The New Standard,” featured Carrie Lewis, senior director of strategy, oversight, and training at Endo Pharmaceuticals in Malvern, PA, and Brian Schilb, the senior director for training solutions at WCG Trifecta.
Benefits of Virtual Training
Lewis said she is a huge supporter of and believer in virtual training and wanted to speak about its benefits. “Of course, COVID has shown us even more than ever that we must be flexible in the way we train.”
Virtual training is convenient, she said. “[A]nyone from a site can attend. Therefore, you’re getting greater volume of attendance, and then greater training coverage.” The number of attendees no longer has to be limited due to budget concerns, and many staff enjoy not needing to travel for the training.
Another convenience is on-demand training capabilities. “This has been a huge benefit in my career to give some more flexibility for the sites to do training at their own speed and at the time that worked for them,” Lewis said. “It also allows you to focus on those key items during the live meeting.” The videos also can include launch codes to confirm that staff has watched them.
Flexibility is another benefit. Dates for virtual training can be scheduled and easily changed. “We sometimes have to shift [our schedules] very quickly, and virtual training gives us the huge advantage to do so,” she noted.
Virtual training still can be fun and interactive, Lewis said. She disagreed with concerns that it can be boring. “We honestly had some of the most fun interactive meetings all from our home. Since it was internal, we did a lot of team-builders. It was so exciting and brought us closer together to see pets, kids, and home offices. I think we really made the best out of that situation and had some fantastic training.”
Some people might multitask during virtual training, but they also multitask during live training. Lewis said she has seen participants reading the newspaper during live investigator meetings. “Unfortunately, multitasking and things like that are something we have to work on across any type of training format,” she lamented.
Lewis has used the game-based learning platform Kahoot! to increase viewer engagement during internal training. The trainers boosted that competition by providing gift cards to the winners. “They were paying attention. They wanted to win. They wanted to be part of that fun interaction and Q&A,” she said. Do not wait until the end for polling or interactive things. “If people are having fun, they will be engaged.”
Excellent virtual training is available and should be embraced, Lewis said. However, the choice should be strategic. For example, a clinical trial was starting a new indication and the sites are not well-known. “We want to have a face-to-face meeting to build those relationships,” Lewis said. In that situation, they held a virtual investigator meeting but plan to attend a conference to meet staff from the trial sites. “There is a lot of room nowadays to think outside the box,” she said. “Think about your current situation and what it means and be flexible.” There might be other ways to do face-to-face time while also using virtual training.
Virtual training is less expensive, but the focus should be on quality, not just money, Lewis said. Still, the money saved from virtual training can be invested into more training or other needs in the clinical development process.
Virtual training can be used for internal training and site training. Using the platform for an investigator meeting for three days of internal training allowed “us to really deliver very robust, effective, interactive, and extremely fun internal training,” Lewis noted. They held a virtual scavenger hunt where members of the teams were laughing and learning about each other. Cameras were mandatory so staff could be seen and more engaged. They even took a “selfie” to capture the moment. “I truly believe everyone paid attention,” she said.
“Virtual training may not always be the best option, but we should not be defaulting to face to face just because we’ve always done it that way,” Lewis said. “We need to think about what’s best for this situation? What would be the best way to provide the information? What would make people want to attend, and what is the best way to keep them engaged so they can learn? There are so many great ideas out there. Think outside the box.”
Virtual Training Savings
Schilb noted COVID-19 has forever changed the way sites conduct their training. “Gone are the days of sites and sponsors gathering in hotel ballrooms or conference rooms to speak and learn about the novel products to cure patients from disease,” he said.
Virtual training has gone from a tool used by a small percentage of sponsors to a “must-have” because of the demands of the COVID-19 pandemic.
Schilb said they studied nine months of data and can now say how leveraging on-demand training with web-based meetings is proving to be the new “norm” in clinical trials. “Statistics show that delivering on-demand training to sites reduces costs by 60%,” he said. “You gain 55 enrollment days on average, and it reduces 50% of sites’ time by eliminating redundant training.” This happens because the training content required to conduct clinical trials can overlap significantly from study to study. “Web-based clinical training through a clinical qualification management system can address many of the issues related to redundant training content.”
For example, a system that applies topic equivalency rules to the site personnel training between and across studies can cut hours of redundancy training for staff. Over four years of use, and with an average of 15 minutes of training time for each topic, clinical site staff working on studies for a sponsor were exempted from 98,166 hours of redundant training, Schilb said.
Content of training is key. Developing training for delivery in a virtual environment, whether on demand or via a web meeting, means an approach to content development that might be a bit more focused than an in-person presentation. “The primary objectives and the endpoints of the study should be driving that content,” Schilb said. “The objective is still the same, to inspire thought-inspired questions, inspire understanding, but the protocol training should highlight aspects of the protocol that carry the most risk.”
Virtual training is not a substitute for protocol review. “It’s a support mechanism,” Schilb explained. “It helps ensure the site staff are aware of what the study team identifies as risk. It’s important when developing training content that you’re boiling it down to the necessary items within that context.”
Another consideration is identifying the optimal training solution for the needs of the trial. “The training solution should be designed to make the task of training easier, not more difficult,” he said. An on-demand training solution also can house ongoing frequently asked question (FAQ) documents and transcribed discussion documents.
Another popular option is an online opportunity for site staff to communicate directly with the study team. “Typically, these meetings may involve a short presentation by the study team,” Schilb said. “Perhaps it’s a few minutes presenting on immediate recruitment challenges or even recruitment successes, highlighting certain aspects of the protocol, even covering recent FAQs that may have been submitted.” Most of these 60- to 90-minute sessions focus on direct questions from the site staff who joined that meeting.
These sessions allow the site staff to ask questions out loud and allow the study team to respond and hold a conversation. The meetings can be divided by site role or time zones. “Allowing the sites an opportunity to be in front of the study team on a regular basis throughout the life of the study can be very impactful,” he said. These sessions can be saved for future reference throughout the life of the study, to be viewed by current and future site staff. Through these meetings, the voice of the site staff also can be heard. “The voice of the site is critical in the success of these endeavors.”
These virtual solutions will not go away, no matter what the global health conditions were, are, or will be, Schilb said. “These solutions were here in the past, but they’ve never been quite so meaningful as they are for us now, globally.” The training that is developed, be it a web meeting or an on-demand training solution, should be focused and purposeful to identify the risks associated with the training, protocol, and labs.
On-demand training solutions allow all study training documentation to be housed in one location, audit-ready, Schilb said. The information can be accessed 24 hours a day, seven days a week from any location. It can be accessed by sites, monitors, and the sponsor team. New staff can view the information immediately. No travel is involved. Amendments to trials can be turned around within 48 hours with site staff given access to the content.
It is important to recognize the way technology has provided improved methods to deliver clinical trial training and to collaborate with sponsor partners, research organizations, vendors, and clinical site staff, Schilb said. “As an industry, we are in some ways more connected now than we have ever been.”