Assessing risk in advance is the key to running a safe, successful clinical trial, says Peggy Fay, PhD, RN, CCRC, a clinical research consultant with Clinical Research Facilitators in Buford, Ga.
The stakes are high. She recently worked on a trial where the sponsor and team did everything right—except consider the possibility the product wouldn’t be manufactured in time. In the case of that troubled trial, all sites were open and everything else was ready to roll.
“You’ve got to try to identify anything that could possibly go wrong and come up with a plan to manage it,” Fay stresses. While the unavailability of a supply of an investigational product is an admittedly rare occurrence, proactive risk assessment is also critical in a more common problem area: lagging trial enrollment. A proactive response plan would prepare staff with information showing early indicators that not enough people were being screened or matching trial criteria.
In such as case, the sponsor and team might ultimately decide to delay the trial. However, they might be able to salvage it if they’ve put a response plan in place. For example, they should have a contingency program that helps the contract research organization (CRO) advertise the trial locally. Often, that late public relations push can keep the trial moving forward. However, coming up with that plan after the shortage has been detected has far lower odds of success, Fay says.
With release of a U.S. Food and Drug Administration guidance document in 2013, sponsors were encouraged to adopt risk-based management and monitoring strategies and plans for investigational studies. That’s the good news. The bad? “Although it opened the door to alternative methods for trial management, there was little guidance on how to implement an effective program,” Fay notes.
Today, the challenge is to be able to integrate data streams into reliable intelligence that allows sponsors, CROs, study teams, and monitors to make more informed and intelligent decisions when risks arise.
Fay, who’s delivering a session at the ACRP 2016 Meeting & Expo, says she’ll walk attendees through a case study where a trial face unanticipated, costly risks and other assorted challenges. “It will take them through metric indicators, mitigation strategies, and tools that sponsors used to detect and manage the risks and associated costs of implementing options and mitigation strategies,” she adds.