Proactive risk management programs can help keep clinical trial budgets on track and “salvage” a trial in duress, says Michael Marotta, MS, a senior project manager with Avania (formerly IMARC Research, Inc.).
He’s a big proponent of leveraging a risk management program at the very outset to, among other things, keep budgets focused on “needs versus wants” when designing a trial. Risk management guidelines can help differentiate between “what you should do in a trial as opposed to what would be ‘nice’ to do,” he adds.
Risk management done right at the front-end can help down the line, too, Marotta says. “If the trial zagged when you expected it to zig,” a risk management program can help when it’s time for a course correction, he notes. Crafted properly, he explains such programs “can help you go back” to earlier points in the trial and salvage work done so far. “It’s tough when you have a multi-year study and you have to start from scratch” after a serious obstacle appears, he says.
“The biggest risk in risk management is not having a risk management plan,” echoes James Moat, CCRA, director of project management services for Avania.
Moat advises bringing in a wide array of clinical trial specialists when developing a risk management program. He includes marketing and data management on the invite. “Get the whole team on board” to better understand consent issues and other potential thorny challenges threatening to delay or derail a trial.
“Clinical operations are obviously a huge hurdle in the development of medical devices,” Moat adds. Pulling together a broad team at the earliest stages means it will usually be easier to handle snafus. “When something [negative] happens, everyone knows what to do” by referring to the risk management document and other support information, he says.
The complexity of the clinical trial will determine the type of risk management program required, Moat says. “Depending on the study, it can be a simple document,” he notes. However, it’s key to address risk issues early on with a full team cohort, he stresses.
Author: Michael Causey