COVID-19
– and predefined actions to be taken if the risk becomes an issue, will reduce the magnitude of the risk and/or issue. There are multiple guidelines available for those who are new to risk management; for example, the ISO standard ISO 31000:2018 Risk Management, among others. According to my dictionary, issue means ‘an
important subject that people are arguing about or discussing’. In the period before a governmental election, this can be the major topic of discussion – even in a study team – but it does not necessarily mean that it will put the clinical study at risk. In other words, it is important for the team to develop a common ground and define the terms, such as issue and risk – as applicable for the study – affecting patient safety, timelines delayed more than a month and budgets overrun by more than 5% or similar. Similarly, I have seen risk logs where almost all risks are scored very high. It is here that it is very important to establish definitions for each level – highest-level impact, for example, if there is a critical safety issue, a budget overrun with more than 10% or similar – both for impact and likelihood.
Potential areas for improvement To be able to take appropriate action at the right time, it is important to understand when a risk becomes an issue. If a risk has occurred, it is no longer a risk but an issue and it is important to take corrective action to reduce the impact as quickly as possible. ICH and GCP has a huge focus on appropriate risk mitigation and management, but often their teams lack the ability to have sufficient oversight of the risks in order to take immediate action. Ongoing review of risks and appropriate communication is, therefore, key. There are two further areas where I have
observed the process fails: the project manager – best case with the project director – lists the risk they see on their own. This means that risks addressed for further proactive actions are often limited to the areas of previous experience and knowledge of the project manager, and many risks are left out. Some companies let the different functions contribute to the risk log, but leave out the common discussion between the team members on how this is affecting the other parties. This leads to an incorrect risk score, as what a specific department sees as having low-impact might have major impact for another function. The best practice is, therefore, where all team members provide their input on the list of risks
and suggestions on how to mitigate it, and then a discussion in the larger forum is held.
“To be able to take appropriate action at the right time, it is important to understand when a risk becomes an issue. If a risk has occurred, it is no longer a risk but an issue and it is important to take corrective action to reduce the impact as quickly as possible.”
The other area is lack of follow up on the risk
register. Separate actions, decisions and issue logs are reviewed at study team meetings, but not the risk actions. Often the process would indicate a review on a three-month basis, but this would be too rare an assessment if the risk has become an issue and a change of course is needed. This leads to actions taken for the issue being initiated by up to three months late. My recommendations would, therefore, be to review the risk log at every study team meeting and train the entire team on the risk log, so it is not a single person’s responsibility to have oversight of these. A communication plan should also be implemented with an escalation plan in case an issue is identified or a risk turns into issue.
Lessons learned from Covid-19 The US movie Contagion (2011) in addition to Outbreak (1995) should have prepared us for a situation like this to happen to some extent. Moreover, situations like this did happen during the Spanish flu pandemic of 1918, the Asian flu pandemic in 1957–58, the Hong Kong flu pandemic in 1968 and most recently the pandemic caused by the influenza A(H1N1) virus in 2009. In other words, we had the best opportunity to be prepared proactively. That being said, on the one hand there was the
risk of spread from patients to site or vice versa, but on the other – and of the greatest consequences for clinical trials – there was the halt or slowdown of recruitment. Have we experienced this before and could have acted proactively to reduce impact of issue? Yes, without a doubt. A solution offered by many was the concept of remote monitoring
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