Enough is enough! Can’t we just accept the risk?

I attended SCOPE Europe 2022 in Barcelona recently. And there were some fascinating presentations and discussions in the RBQM track. One that really got me thinking was Anna Grudnicka’s on risk acceptance. When risks are identified and evaluated as part of RBQM, the focus of the team should move to how to reduce the overall risk to trial participants and the ability to draw accurate conclusions from the trial. Typically, the team takes each risk, starting with those that score the highest and decides how to reduce the scores. To reduce the risk scores (“control the risk”), they can try to make the risk less likely to occur, to reduce the impact if it does occur (a contingency) or to improve the detection of the risk (with a KRI, for example). It is unusual for there to be no existing controls for a risk. Clinical trials are not new, after all, and we already have SOPs, training, systems, monitoring, data review, etc. There are many ways we try to control existing risks. In her presentation, Anna was making the point that sometimes it may be the right thing to actually accept a risk without adding further controls. She described how at AstraZeneca they can estimate the programming cost for an additional Key Risk Indicator (a detection method) and to use this to help make the decision on whether to implement this additional risk control or not.

Indeed, the decision on whether to add further controls is always a balance. What is the potential cost of those controls? And what is the potential benefit? Thinking of a non-clinical trial example, there are many level crossings in the UK. This is where a train line crosses a road at the same level. Some of these level crossings have no gates – only flashing lights. A better control would be to have gates that stop vehicles going onto the track as a train approaches. But even better would be a bridge. But, of course, these all have different costs and it isn’t practical to have a bridge to replace every level crossing. So most level crossings have barriers. But for less well-used crossings, where the likelihood of collision is lower, the flashing light version is considered to be enough and the risk is accepted. The balance of cost and benefit means the additional cost of barriers is not considered worth it for the potential gain.

So, when deciding whether to add further controls, you should consider the cost of those controls and the potential benefits. Neither side of the equation may be that easy to determine – but I suspect the cost is the easier of the two. We could estimate the cost of additional training or programming and monitoring of a new KRI. But how do we determine the benefit of the additional control? In the absence of data, this is always going to be a judgement.

The important thing to remember is that not all risks on your risk register need to have additional controls. Make sure the controls you add are as cost-effective as possible and meet the goal of reducing the overall risk to trial participants and the ability to draw accurate conclusions from the trial.