Pharma companies, sponsors and contract research organizations are under tremendous pressure to bring new products to market safely, on time, on budget, and in compliance with the stringent Guideline for Good Clinical Practice (GCP) set out by International Council for Harmonization’s (ICH) E6(R2).
The process is complex and the risks can be consequential. New standards of governance over on-site activities and the implementation of risk-based monitoring (RBM) are essential to mitigating against adverse events and putting patients at risk. It is absolutely critical to spot potential problems before they happen.
As such, clinical leaders and training managers have the responsibility to ensure site monitors are equipped to record clinical research data accurately and securely – to, first and foremost, minimize patient risk, as well as keeping new drug launches on time and on budget by avoiding errors or misrepresentations. It’s a task that is easier said than done.
And while the new industry standard of risk-based, centralized monitoring has proven advantageous from both a cost and productivity perspective, the pace of change in industry regulations and sponsor standard operating procedures (SOPs) is constant. It may seem impossible for site monitors to keep up, which is why targeted and continuous support, training, and coaching is essential.
So, how? We’ve identified the following three strategies for clinical research leaders and training managers to improve site monitoring outcomes:
- The Pareto principle: Better known as the 80/20 rule, which in this example means that roughly 80% of effects come from 20% of the causes. In an RBM model, clinical leaders should start with vulnerabilities that present the most risk when building site monitor training programs. By identifying and focusing on critical flaws in site monitor process adherence or knowledge gaps that could result in the most serious or volume of potential or actual adverse events, clinical research organizations (CROs) can have a big impact on minimizing patient risk, while also streamlining the time to market of new drugs.
- Make site monitor learning ongoing and part of the workday: For many people, the idea of training and learning invokes images of classrooms, eLearning modules, and sheer volumes of information that will be quickly forgotten if not effectively reinforced and applied on the job. Research has proven, however, that ongoing contextual microlearning strategies incorporated into employees’ workdays has significant advantages with monitoring and reinforcing competencies. Look for a microlearning platform that makes ongoing training easy for site monitors and their managers alike – available on any device, in the flow of a normal workday, using short, scenario-based challenges that will ultimately impact behaviors.
- Continually identify knowledge gaps and implement precision-based training: Invest in tools that help managers identify knowledge gaps of site monitors so they can focus their time on targeted coaching at an individual or group level where it is needed most. Training leaders need measurable data on proficiency against critical subject areas to identify knowledge gaps and develop precision learning programs. Managers also benefit from this data so that they can coach efficiently at an individual level. Clinical ops leaders need actionable data to get a real-time picture of the overall field understanding to identify possible risks to patients and launch plans.
By applying these best practices, especially in phase 2 and 3 clinical trial programs, pharma and life sciences companies can reduce the cost of training significantly, while also realizing other benefits such as:
- Faster study execution: Even incremental gains in job proficiency can have a real impact on costs and time to market, both of which can be measured in millions of dollars when it comes to new drug development.
- Improved study quality: Site monitors are vitally important to data gathering and reporting. The better the monitors, the better the data, and the better the study. Of course there are a lot of factors that impact study quality, but human error is among the most common (and most costly).
- Increase study team productivity: With clinical sites typically distributed across the globe, centralizing trial data and operations is both critical and complex. Ensuring that teams of site monitors are working effectively and efficiently reporting into the trial sponsor is among the most important aspects of the job.
There is clearly plenty of overlap between this use case and any complex, highly regulated team-based programs, but in pharma and life sciences, the stakes are particularly high.
If you are involved with clinical operations or another risk-based organization, you may be interested in this webcast replay Mitigating Against Adverse Events: A Game Changer for Risk-based Monitoring. This Q&A session gives tips on how to improve monitor effectiveness.