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Clinical Trial Metrics: Study Health Vital Signs

Is there a way to see at a glance how well my clinical study is doing?

Whether I'm talking to a study manager, data manager, supply chain manager, or executive, this is a question I hear again and again when discussing eClinical systems reporting.

The good news is, yes. There is a way to get a quick sense of the state of health your study is currently in. It is through the use of metrics. Leveraged properly, they can answer three of the most common questions concerning clinical trial health:

  • Is the study on track?
  • What are the trouble areas?
  • Which sites are experiencing difficulties?

Clinical trial metrics provide sponsors a framework to understand and measure at a glance the various activities comprising the trial. They let you set expectations, and then assess site and study performance against those expectations. Used correctly, metrics allow sponsors to distinguish well-performing sites from those that require improvement and to identify potential problem areas early before they escalate and further impact quality and performance.

What Metrics to Focus On

When getting started with metrics, it can seem overwhelming to choose from the abundance of available information and where to focus. Fortunately, in just about every study, stakeholders tend to ask a similar set of important questions. This means you can generally rely on using the same set of metrics from one study to the next.

The first metrics to keep a watchful eye on are site activation and subject enrollment vs. plan. Together, these indicate whether your study is on track to enroll the subjects it needs in order to obtain the necessary clinical data. They also tell how well actual enrollment is progressing. These metrics form the foundation of any study, and also provide some of the earliest indication when a study is possibly veering off track.

If enrollment is under control, another important area of focus is data collection and query or discrepancy rates. Together, these metrics can tell you if sites are entering all of the required data and if it is high quality. They also can be leveraged to project data management workload, and by extension, how long it will take to verify and lock data. Later in the study, the percentage of forms verified and locked will become critical to watch.

The most important thing when setting out to use metrics to see how your study is really doing is to start small. Concentrate on a few high priority, easy-to-build and easy-to-digest metrics. These are the kind that won't answer every question, but they will answer those questions that tend to keep study managers up at night. Once you've got the basics down and are comfortable working with them, you can expand and explore additional metrics and different ways of using them.

Drop me a line and let me know how you are using metrics. If you would like to learn more about study metrics, join me for a live webinar I'm hosting on May 22, Using Metrics to Measure the Health of Clinical Trials. This one-hour webinar will show you how to leverage the data from your various eClinical systems to create eye-opening performance metrics. Participants will also learn how easy it can be to quickly assess the health of studies and identify and address problem areas early for overall improved quality and performance.

I hope you will join me!

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