Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites
Risk management may be an integral part of conducting a trial, but in the past year sites have been overwhelmed with emergency measures needed to keep their trials running, leaving them little time to attend to the formal processes of identifying, assessing and mitigating risk. As the COVID-19 crisis eases in coming months, however, sites will need to refocus their attention and efforts on their risk management programs.
How they do that will depend largely on the size and experience of their staff.
“I worry that with the events of the last year, some of these risk management plans may have taken a back seat,” says Sandra Smith, senior vice president for clinical solutions and strategic partnerships at WCG Clinical. “So now, as people are coming into the normal workflows, they’re playing a little bit of catch-up,” Smith says.
But catching up with risk management could be difficult for some sites, especially smaller ones, she says. While larger organizations may have personnel they can dedicate to assessing risk and areas of past failures, smaller sites’ staff already divide their attention among a variety of trial management tasks. “They just don’t have that diversity of resources or the head count,” she says, to devote strictly to managing risk.
Jill Heinz, director of clinical research at Injury Care Research, agrees that larger sites have more resources to apply to risk management. “In my experience, the larger sites seem to have this under control a bit better because, as they’ve grown and have more personnel, they also have the capacity to hire for positions that address this,” Heinz told CenterWatch Weekly. But small sites have their own advantages when dealing with risk, she says. “Smaller sites have the ability to pivot and adapt quicker when perceived risks are brought to light. So, there is really a benefit to both models.”
For smaller sites that don’t have the capability to hire someone to conduct risk management, training and assigning the responsibility to a CRC might be enough, Heinz says. “Even if a checklist was created that staff talked through when a new protocol was being initiated, [that] would be a good start. Then, bring that list back out each month or quarter to see if the risks and mitigation techniques are working as planned.”
One tool sites can use as a kind of shortcut to identify the risks their trials face, says Laurie Halloran of Halloran Consulting Group, is the report of results from site qualification visits and interviews sponsors conduct when choosing sites to conduct their trials.
Site qualification is “very much a job interview and assessment of the site’s people, process and quality,” Halloran told CenterWatch Weekly. Gaps, weaknesses and areas of doubt discovered by sponsors can be used as an almost ready-made list of risk factors that need to be addressed, she said. “Sites should use the qualification as a way to learn more about what they should do better.”
Smith agrees. “Where this becomes incredibly important is when the prestudy visits are done and the sponsors and CROs have essentially been put in the role of assessing the viability of the site,” she said. “In essence, what they are doing is looking at what the potential concerns are, what the likelihood is that they are significant or not, and [whether] they could be overcome.”
Risks of high severity and likelihood should be eliminated from a trial, while lower-severity risks or those less likely to occur can be mitigated through such measures as liability insurance or the use of a data safety monitoring board. Risks at the lowest end of the scale could just end up being tolerated, Smith says. “This is a hard thing for sites because everyone is an optimist and they think they’ll be able to address [a problem],” Smith says.
Rebecca Scott, product support specialist at HealthStream, encourages sites to use a three-pronged risk management approach outlined by the Institute of Internal Auditors’ (IIA). According to IIA’s Three Lines of Defense Model, sites’ risk management programs include:
- Oversight by a governing board, which provides accountability to stakeholders for organizational oversight;
- Actions by management and operational leaders to achieve organizational objectives, including managing risk (first- and second-line roles); and
- Independent assurance through an internal audit (third-line role).
While all of the aforementioned tools “are great and worthy endeavors,” Heinz says that in the real world, sites don’t use them as often as they could. “When we’re scrambling to onboard a study, sometimes they’re not practical. We’re fighting against quickly getting a study up and running due to sponsor pressures and competitive enrollment as well as ensuring we conduct some of these risk assessments so we can ensure quality data. It’s a balancing act.”
Smith emphasizes that sites thoroughly document every part of their risk identification, assessment and mitigation strategies in order to protect quality assurance and compliance. Documentation gives a site and regulators the ability to reconstruct a trial as it happened and allows independent observers to confirm the results.
One common mistake among sites, according to Heinz, is calling a halt to their risk management practices once they believe all risk has been fully mitigated. “A site identifies and assesses a potential risk, they take action to mitigate it and then stop there,” she says. “Part of risk management is circling back to review if that specific action was effective.” She added that sites should ask themselves if they could have done things differently or if their mitigation action caused other issues. “I know I’ve been guilty of not fully finishing the cycle and have learned that lesson the hard way.”
“There is always value for sites to look at both themselves and others,” Halloran agrees. “There is no such thing as perfection, every study is its own set of complexities and opportunities for improvement. One big thing is to cultivate a culture of both quality and continuous improvement, encourage project postmortem improvement discussions and a culture of education.” Sites that depend on continuing a relationship with sponsors, she says, “do these things and ideally learn from their mistakes.”