NASHVILLE — Attendees at last week’s ACRP 2019 conference discussed and debated a number of diverse clinical research topics, but the buzz about improving clinical monitor and coordinator training came through loud and clear in several sessions.
The clinical trial professional of the future will need the skills to deal with increasingly complex protocols, risk-driven trial strategies, ever-evolving technologies, virtual environments and more, speakers agreed.
Risk-based monitoring (RBM) has become a particularly challenging issue and one that means different things to different people, according to a panel of trial coordinators and managers. Too often, RBM has been translated into remote monitoring. What it should be, said Lynn King, executive director of clinical management for PPD, is a shift from detecting error to detecting risk. Trial monitors should be spending time looking at the most important data and trends rather than weeding out problems across all data, agreed her co-panelists: Jaylene Weigel, director of clinical research operations for Children’s Mercy Hospital in Kansas City; Patricia Cataruozolo, director of clinical site management at Pfizer; and Tegan Mead, associate director of healthcare engagement at Javara.
The subject of technology training came up in several sessions. According to a survey by ACRP and Forte, only 66 percent of more than 1,200 respondents said they had received adequate initial training on the technology applications required in their jobs. “One out of three members of your staff feel they don’t get adequate initial training,” said Forte Director of Analytics Wendy Tate. “That is a really concerning statistic.”
And only 43 percent of respondents to the survey said they get ongoing training. “As we all know, technology changes,” Tate said. “You have new versions, you have new updates, new regulations driving new reporting requirements.”
There are a variety of training methods available to help close skill gaps. The key is matching the need to the right tool, according to Annette Bernstein, senior training manager at Johnson & Johnson, and Sandra Hines, PRA Health Sciences manager of clinical operations. Kick-off and investigator meetings benefit from “face-to-face” interactions and are a good venue for bringing trainees together with subject matter experts on a particular trial. On-line courses are the best choice for training on company procedures and computer systems.
But direct exposure to the job, such as on-the-job training, coaching and co-monitoring, can be the best option. “Jumping right into work from day one can sometimes be the most effective type of training,” Bernstein and Hines said.
No matter what type of training is used, timing is key, they said. Provide instruction too far in advance, and the trainee won’t retain as much when it comes time to apply the lessons. Instead, Hines and Bernstein recommend, break training into concise modules and deliver them as close as possible to the time the trainee will use the information. “They’ll retain more, and you’ll waste less time having to retrain overloaded monitors.”
Overall, one theme came through clearly at the conference. In the rapidly evolving digital and technological world in which we operate, training should be never-ending. There will always be new lessons to learn.
Consider the message delivered by WIRB-Copernicus Group Chairman and CEO Donald Deieso in a panel on the future of the clinical trials workforce. “In 18 months, half of what we know now will be irrelevant.”