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I’ve not fallen down the stairs today… not yet anyway…

21st Aug 2014

Chad Finch, CIO Triumph

Why does the clinical trials industry keep trying to evaluate site risk based on issues at the site which have already occurred?…….

When evaluating a site we certainly need to be aware of critical data entry errors, poor protocol adherence and unusual AE reporting; but at the point we become aware of these items it is the automotive equivalent to having already had an accident or two on the site’s driving record. It’s economically vital that the auto insurance industry assess a customer’s level of risk whether they have prior incidents or not.  That industry knows precisely the risk associated with an individual by the customer demographics.  They have studied the relationship between a demographic, a behaviour and the likelihood of a particular result in order to understand the risk that an individual poses.

Is it possible that the clinical trials industry can understand site demographics, attributes and/or behaviour sufficiently to accurately predict risk?  We at Triumph believe it is.  In order to accomplish this we had to stop looking just at how many and what types of issues sites are having and start understanding the attributes and behaviours of sites which deliver high quality data vs. those who do not.

One step is this direction is looking for patterns of behaviour that are exhibited by sites and finding the ones that distinguish quality practice from the lack of.  The number of times I fall down the stairs per year may be a metric that could be used to determine how likely I am to experience an injury at home.  At the point I have fallen down, an opportunity has already been missed though.  So it would be much better to have a leading indicator that could identify the risk before I fall.  It’s generally accepted that leaving things on the stairs is a poor practice and that holding the handrail is a good practice.  It is not news to any of you reading this that there is a relationship between leaving things on the stairs and injury at home.  It’s this type of behavioural evaluation that is making the real difference with evaluating site quality and site risk.

Don’t get me wrong, the ongoing metrics and standardization efforts within the industry are a big step forward, but I get the sense that the line between evaluating current or past site performance and predicting quality is still quite fuzzy in many cases, but need to be separated to truly predict quality risk.

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