Anyone in charge of L&D in rapidly changing and complex environments knows it can be hard for employees to keep up. The knowledge and skills needed to do any job optimally keep evolving or become obsolete, making it difficult to benchmark and assess job proficiency at a given point in time. This is especially true for clinical trial training programs which are adapted regularly based on data inputs and analysis.
Structural occupational changes such as the adoption of centralized, risk-based monitoring are streamlining clinical trial monitoring while adding complexity for trainers. One-off training is not sufficient to enable site monitors to constantly adjust focus and activities to new areas of greatest need that have the most potential to impact patient safety and data quality.
Plus, this approach comes with changes in regulations and standard operating procedures (SOPs), which increase the risk of non-compliance, delays or even adverse events. Guidance from the US Food and Drug Administration (FDA) stipulates that the monitoring plan to be developed is responsible for communicating risks and monitoring procedures to everyone involved in monitoring the trial.
With a little assistance from microlearning techniques, a continuous training strategy can be implemented that enables site monitors and teams to reach the job proficiency required to minimize data errors and improve safety of the study.
Microlearning involves delivering bite-sized, targeted training and is a great complement to learning management systems (LMS). Microlearning provides the opportunity to employ the ADDIE instructional systems design model — Analysis, Design, Development, Implementation, and Evaluation — in a rapidly changing environment to continuously improve individual monitor proficiency despite changing regulations, best practices and SOPs. Here’s how:
Analysis — Understanding what monitors know and don’t know is paramount when training clinical ops teams. Each monitor brings a different set of skills and competencies so a one-size-fits-all approach won’t necessarily improve individual proficiency, which can have significant consequences for clinical trial teams.
Microlearning helps diagnose potential skill and competency gaps. Knowledge recall degrades over time, and it can be hard to determine what has been retained (or not). Microlearning enables you to assess knowledge gaps and train more effectively by focusing on the areas of need.
Design and development — A huge amount of resources are spent on developing the often complex and detailed core curriculum for clinical operations teams. It doesn’t make sense to recreate the wheel each time there is a data integrity issue. However, when there is an ongoing assessment, trial team leads know who, what, and where to train, with microlearning as a tool to fill in the knowledge gaps. For example, training content delivered in short scenario-based challenges, deliberately spaced to maximize recall in accordance with spaced learning theory vastly improves knowledge recall and is proven to change behavior.
Likewise, when clinical trial team leaders know who, what, and where to train, coaching time can be used far more efficiently by only addressing knowledge gaps. We think of it as “microcoaching”: targeted coaching where it is needed most for an individual. In many cases, just minutes of well-spent time can have a big impact on site monitor productivity and compliance.
Evaluation — As we know, learning does not end when the course is over or the test is taken. This is especially true in highly regulated work environments such as clinical trials where the only constant is change — change in regulations, change in best practices, changes in SOPs, and so on. It’s a continuous effort with no beginning or end. Even if you can achieve 100 percent job proficiency, recall fades and conditions change.
For site monitors and clinical operations teams, job proficiency can have a direct impact on patient safety, study outcomes and speed to market of new drugs. The ability to collect and correctly interpret participant data is critical with changing parameters for research teams in making informed decisions about next steps.
To learn more about how microlearning can help and complement your clinical trials, watch our webinar, Reduce Clinical Trial Risk with RBM and Microlearning Best Practice.