Ideas that matter

Filling in the Knowledge Gaps of a Clinical Trial Site Monitoring Team

You’ve spent countless hours of preparation setting up your clinical trial, finding the right team to staff it, and have set the final pieces into motion. But no matter how meticulous you’ve been in the pre-trial process, there is still no certainty that the trial will run smoothly. At worst, you don’t want to be another statistic – of a clinical trial being aborted before the patient enrollment stage.

There are plenty of obstacles with clinical trials that have detrimental consequences: delaying time to market for new drugs, large financial losses, and even terminated trials. These unfortunate outcomes can arise from discrepancies within the procedures followed by clinical trial site monitors.

  • Are they following the proper protocols for gathering and recording data?
  • Are they using the same techniques in different sites?
  • Are they working in compliance with regulations and standard operating procedures (SOPs)?

When relying on the consistency of multiple raters, it can be hard to guarantee that all of these things are happening as they should each and every single time.

Typically, clinical trial raters undergo intensive training to ensure the highest degree of accuracy possible. But with clinical trials lasting for several years, knowledge retention from initial training depletes over time, leaving the study vulnerable to mistakes that can derail the whole operation. “The Forgetting Curve,” as coined by German psychologist Hermann Ebbinghaus, shows that knowledge retention drops exponentially from minutes, to hours, to days after initial instruction — up to 79% of new information, gone.

So how can clinical leaders and training managers combat this phenomenon? Identifying knowledge gaps of clinical trial teams and effectively addressing them during the trial or as trial conditions change, not just at the outset, can be the key to avoiding costly mistakes.

Microlearning, or continuously providing information in small doses and testing on it, is the solution. Imagine being able to assess your raters early on in the trial only to find that there was an area of regulatory compliance that was unclear to members of the team from the outset. If you can address knowledge gaps with educational information right away, a potentially damaging error could be prevented before it had the chance to happen. Microlearning tools enable a continual assessment of knowledge gaps of your team, so management can prioritize the most important areas to improve (or not to focus on), and address them quickly and effectively.

Training is not just a one and done encounter. To be truly impactful, education needs to be continuous. No matter how well a clinical trial team may prepared, they’re only human. Understanding their weak spots early and coaching or retraining against these  will pave the way to have the right knowledge and more chance to keep a trial on track with accurate data collection and input. To learn more about the beneficial role that microlearning can play in clinical operations or other risk-based organizations, listen to our webcast, Mitigating Against Adverse Events: A Game Changer for Risk-based Monitoring.

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