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We'll start our monthly metrics blog with a basic but crucial MCC Clinical Trial Performance metric: on-time site initiation.
We’ll start our monthly metrics blog with a basic but crucial MCC Clinical Trial Performance metric: on-time site initiation.
Why this metric is important: Achieving on-time site initiation is a leading indicator for meeting subject enrollment. Unless all of your sites are initiated in a timely manner, your subject enrollment is guaranteed to be late. Late enrollment leads to last-minute panics, and last-minute panics consume lots of unplanned resources.
Definition: At the MCC, we define on-time site initiation as the ability to initiate the number of sites planned on the date planned. We use the 25%, 50% and 75% points in the site initiation process for our metric. That means that if you’ve planned to start your site initiation on Jan 1 and have 25% of your 40 sites initiated by June 1, then you’ve met your goal if 10 sites were initiated by June 1, and so on.
How to calculate this metric: You simply divide (the number of sites initiated as of the plan date) by (the number of sites planned to be initiated by that date). So for our example, 10 sites were to be initiated by June 1. If only 8 sites were actually initiated, the calculated metric would be 80%. On the other hand, if 11 sites were actually initiated, the calculated metric would be 110%.
What you need in order to measure this: You need a plan date and actual date for each site. That means you need either a complete, site-by-site plan, or at least a first site and last site plan along with a site initiation curve (a simple y=x2 curve works pretty well).
What makes performance on this metric hard to achieve: You need a good set of planned site initiation dates that you know you can achieve with the resources that you have. You also need your investigational product ready for each site initiation.
Things that you can do to improve performance: First, make sure that you’ve got a solid, achievable initiation plan (site selection, ethical reviews and contracts, drug shipment, site initiation, and start-up cycle times all tend to be overoptimistic). Then make sure that training, monitoring and contracting resources are available and investigational product is ready to ship. Finally, make sure your protocol is solid and there aren’t any pending amendments that will slow things down.
Companion metrics: Other metrics that you should consider in tandem with this metric include: Site Assessment Quality, Regulatory Package Approval Rate, Site Activation to First Subject First Visit Cycle Time.
Example: In the following graph, the blue line represents the planned site initiation schedule. It starts off slow – it takes half the site initiation period or until Feb 14 to get to the 25% initiation point – but then picks up speed, hitting the 50% point on Mar 5 and the 75% point on Mar 18. Meanwhile, by the planned 25% date of Feb 14, the red dot shows we’ve actually initiated only 10% of our sites, so the metric is 0.4. But by Mar 18 our actuals have caught up and our metric is 1.0.
Figure 1: Planned vs Actual Site Initiation Schedule
CEO, Metrics Champion Consortium