PAREXEL - Drew Garty speaks on the importance of data driven monitoring
Data driven monitoring brings together four key modern monitoring approaches and methodologies. The first, targeting monitoring, breaks down what what previously pre-plannned visit structures, consistent across all sites and focuses on the sites that have the most workload. This included some levels of risk, but as the industry has adopted risk-based monitoring approaches and begins to grow in that area, risk-based monitoring focuses on key measures of risk, turns them into key risk indicators and those are used in conjunction with targeted monitoring to influence exactly when you should go to the site, both improving effectiveness and quality and patient safety. Centralized and remote monitoring extends that in this critical-to-risk based SDV in that it brings together the analysts who can look for additional signals and understand the risks within the study because risk is fluid and must be continuously monitored and adjusted accordingly. Lastly, data driven monitoring brings together the risk based SDV. Source Data Verification accounts for the distinct majority of time spent, by CRAs, on site in site monitoring. Any effect of that would have great reductions in overall costs. But the key is to make sure that we maintain the consistent quality that is expected and required. To do this, we focus on critical risk end-point strategies. Looking at the variables that are most important to the overall study design, submission and defense, and making sure that those have the appropriate levels of SDV or review. Beyond that, there are other decreased risk based approaches for the other secondary end-point values. What data driven monitoring does for us in the industry is that it gives us a great step forward, away from traditional monitoring. It gives us the information and the insights that we can use to improve quality and reduce costs. That is only if we understand the overall cost of our risk mitigation activities. The data driven monitoring solution provides a complete end-to-end cycle of continual process improvement. By measuring the risks and the associated risk mitigation activities and their subsequent costs, we can look at the effectiveness of those activities. Through continual process improvement, we can see the effectiveness of our changes. We have closed the loop and improved quality, patient safety and reduced clinical trial costs.