Sites and site monitors would be well advised to raise the bar when it comes to employing rigorous risk management tools and tactics before jumping headfirst into a clinical trial, say two clinical research thought leaders.
The benefits of employing a robust risk management program are clear: “It can help prevent protocol deviations” and improve overall trial efficiency and speed, says Liz Wool, RN, BSN, CCRA, CMT, president of Wool Consulting Group.
Risk management can give sites and site monitors much more control of their own professional destinies, Wool says, in part because it helps identify potential trial trouble spots before they become bigger problems. “Risk management can provide you with a better evaluation of what you need in terms of resources, timing, and training,” Wool adds. It can also shorten learning curves before and during the trial.
“Sites have to start shifting the paradigm to be more proactive” from the very beginning, says Wool. It’s exciting to win the trial business, but it’s also a dangerous time from a business standpoint because a site might not understand everything it’s being expected to do. Don’t let the thrill of winning the business cloud critical thinking in terms of what you can and cannot realistically do as a site.
At its core, an effective risk management program comes down to addressing two components: 1) What needs to go right? and 2) What could go wrong?
A rigorous and leading-edge risk management program can help anticipate, remove, or mitigate unexpected obstacles in the area of study visits and subject screening, Wool says. Sites lacking such a program often fall victim to “leaning too heavily on the standard of care definition” of a given procedure, she notes. The problem, from a service and business standpoint, is standard of care definitions often “miss nuances that will end up costing the site more in time and money,” she says.
For example, the standard of care definition of a procedure might not mandate a treatment be administered via IV. However, the trial timing might require the drug be given to patients in that manner in order to meet testing protocol. A site that didn’t anticipate the issue might end up missing key deadlines and/or enduring otherwise avoidable protocol violations, she notes.
“It is critical for sites and site monitors to get this right,” Wool stresses. “Sites are usually the first touch points with patients in trials.”
Author: Michael Causey