Evaluating Risk: Is Your Staff Clinical Trial Ready?

Does this scenario ring a bell?

Your trial is about to go live – and given the months (or years) that have gone into planning, site selection, and site start-up – you pause to ask yourself whether your sites or staff are ready?

If you are like most, there is little objective evidence to draw from to confidently answer the question. It’s typical that the only indications of readiness you may have going into a trial are historical performance of a site which is generally tied to a PI or particulars around study design (and not the specific team/members), and/or whether minimal training requirements have been completed. More advanced organizations may have some record of passing test scores for some assigned training, but we all know that, “…knowledge rarely equals performance!”

As such, evaluating risk following initiation traditionally relies on trailing performance indicators that may not be recognized for weeks or months, which forces sponsors/CROs to be reactive as issues arise and snowball at scale. For example, you may find yourself reacting to high screen failure rates, slow enrollment, the number of protocol deviations per subject, delayed data entry, or redundant trial queries or requests for clarification.

Worse yet, understanding the prioritization or significance of these trailing indicators requires more delayed reaction to both diagnose the root cause of each challenge and to devise and implement solutions. This effort could take weeks or months, meanwhile the delays grow, the deviations mount, and time and money is wasted.

Finally, the inability to assess and predict readiness of an individual site or staff member leads to treating each site and all staff the same. If remediation or additional support is necessary, it is often one-size-fits-all – a recipe for failure!

These problems are nearly universal, but they are not inevitable.

 

Understanding the readiness of sites and staff using predictive/leading indicators is a silver bullet. And generating these data while executing on other critical steps in site start-up and investigator/staff training means you can effectively kill two birds with one stone. Over the past 7 years, ArcheMedX has pioneered a new training and readiness model that improves and evaluates the knowledge, confidence, and mindsets of learners, teams, and sites to effectively predict trial challenges BEFORE they happen. Let us help you gain the confidence knowing that your sites and staff are Ready!

 

Learn how ArcheMedX enables peak clinical trial readiness by delivering personalized learning experiences that generate actionable insights.