By Deborah Borfitz 

March 9, 2020 | Pfizer has teamed up with digital training company Gronstedt Group to bring virtual reality (VR) simulations to investigative sites as a way of improving compliance with clinical trial protocols, including the way study drugs get compounded. The VR solution was demonstrated live during a recent co-presentation at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.  

Anders Gronstedt, PhD, founder and president of the Gronstedt Group, refers to the solution as “flight sim” for clinical trials. The maturing technology, which has only been on the market for three years, can be used both to help prepare an investigational product as well as train clinical trial investigators on complex study protocols, he says. 

A mobile VR headset is one of the latest additions to the simulation training tool, but Gronstedt stayed tethered to a PC during the demo to share a user’s view on the conference screen of the “roomscape” created for pharmacist training. During such simulations, users get a live lab experience that includes a view of their own hands that can reach and grab objects in the room. 

The next planned additions to the tool include sound effects and voiceovers by virtual instructors, says Gronstedt. Tutorials inside the VR experience are also being developed showing how to correctly execute each step in the compounding process. Pharmacists may be nervous when first creating a new drug in real life, he says, and the VR solution gives them the option to “train in a safe environment and learn by doing.” 

Simulations have both physical and cognitive fidelity, notes Gronstedt, and are “better than the live experience. [Trainees] will have an instructor over their shoulder providing immediate feedback.” The tool can be used like a virtual classroom for peer-to-peer learning, and “very easily” be expanded from one to multiple clinical trials.  

Pfizer will soon use the technology across multiple sites, says Brendan O’Neill, senior director of patient recruitment programs for the company’s global product development team. It’s a “great option” for phase II and III training and compliance purposes. “[Studies] can be difficult, expensive and we have limited supplies, so we need to be sure [everyone is] following the protocol.” 

The simulation tool will have utility for complex studies and be available as needed for all new investigative sites, says O’Neill. VR training will begin this April in Europe, and then expand around the globe, for a study protocol that is expected to be finalized within the year. VR training is expected to be used for no more than 3% of the more than 200 studies Pfizer conducts each year.  

Although the focus is currently on protocol compliance, O’Neill says, the future could include more non-traditional, simulation-based training on patient engagement for rare disease studies and family engagement when trial participants are not all ambulatory. Pfizer seeks out “very experienced sites” when creating simulations to ensure they feel genuine and instill best practices, he adds.