Centralized monitoring has become a popular approach in on-site and off-site monitoring plans for clinical trials as technological progression enables more data-driven clinical research. Centralized monitoring conducts risk analysis while based remotely in a single location outside of clinical research sites, monitoring through frequent statistical data observation, evaluation of accumulated data, and reporting for mitigation strategies. This results in multiple benefits to the quality, speed, and cost of clinical trials.
Risk-based monitoring is becoming more widely used in clinical trials, as it allows sponsors to focus on the most imperative targeted data and uses thresholds to trigger more detailed monitoring. As one strategy of risk-based quality management (RBQM) for clinical research, centralized monitoring boosts quality and efficiency, as remote activity enables a focus on critical data and processes across multiple sites or across patients within a clinical research organization while identifying and addressing missing and inconsistent data. Centralized monitoring observes and reacts to trends and outliers, using data to identify which site areas, sponsors, or CROs may need adjustment. This has made centralized monitoring a critical part of modern RBQM strategies for clinical research, using weekly to monthly reporting to keep protocols, SOPs, GCPs and data quality on track.
3 Key Benefits
Some regulatory agencies have crafted guidance for risk-based quality management and the risk-based approach to monitoring, which incorporate centralized monitoring. The FDA, EMA, and MHRA all view centralized monitoring as one of the most appropriate cost-effective, suitable approaches to clinical trial monitoring for improving data quality and prioritizing patient safety.
1. High Quality
One of the most effective ways of ensuring a high level of data quality and overall clinical trial quality is through implementing centralized monitoring. The FDA believes centralized monitoring is able to identify nearly 90% of on-site monitoring findings. Centralized monitoring improves patient safety with data tracking to understand which variables are impacting the efficacy of the clinical trial, improving trial integrity among multiple sites. Centralized monitoring also helps uncover abnormalities early on, allowing for adjustments and corrections, which helps decrease the time to marketing approval and resulting in overall higher quality regulatory submissions.
Centralized monitoring can help rapidly identify the highest-risk sites, enabling prioritization by targeting sites with the most imperative issues. It also enables site staff to adjust to these issues confidently through planned mitigation methods that are developed in a centralized monitoring implementation, preventing larger problems from arising through communication and focused resources. This keeps the clinical trial results valid and protects the trial subjects.
3. Cost Efficiency
Monitoring and clinical process validation can require a large amount of people and financial resources, so centralized monitoring can help lessen the resources needed. On-site monitoring often accounts for 25% to 30% of overall clinical trial costs, so using centralized monitoring can make a significant impact by reducing the need for frequent and costly on-site visits and optimizing the fewer necessary visits. With centralized monitoring, these visits can be less frequent and less extensive as they are paired with reliable data. However, centralized monitoring may still require a software investment depending on the sponsor and sites, though some capabilities for centralized monitoring may already be in place. Still, it can help impact spending for the overall clinical trial, including the resulting treatment cost, as clinical trials become more cohesively operated.
Implementing Centralized Monitoring
There are a few essential steps required in order to implement. First, it is important to identify potential key risks and the thresholds and impacts of those risks. Additionally, develop mitigation efforts to respond to any issues, and generate a detailed plan. A plan should include steps for monitoring and documentation to prevent any similar issues from occurring in the future. Documentation for both centralized monitoring and the related risk management plan is necessary and should include metrics, reporting, any changes or issues, and the related results. Metrics can prioritize efficiency, safety, time, and financial impact, all of which demonstrate the effectiveness. The plan should also include details about team member roles, on-site monitoring visit processes, and other centralized monitoring activities, such as strategies for incorporating newly identified risks or other operational changes.
It is important to consider who to hire to effectively implement centralized monitoring. Statisticians can be a good option because of the various statistical processes involved in centralized monitoring, though professionals with experience in research or data management can also be well prepared for a position as a central monitor. Key responsibilities for a central monitor include the ability to identify and mitigate risk with critical thinking, using qualitative information along with other collected data to interpret risks and mitigation in context. A central monitor must be skilled in communications to keep the process traceable and transparent, especially in reporting, including analysis for the root causes of outliers and why any particular mitigation strategies were selected. A central monitor may also need to communicate training needs or staffing adjustments based on findings through remote data tracking and reporting.
Investing in the right tools for data analysis can help with effective centralized monitoring implementation. Some key processes include statistical monitoring of key risk indicators or quality tolerance limits through data visualization. As there is not one single approach to finding outliers, leveraging robust technology solutions that rely on data analytics and artificial intelligence can help ensure early detection and the highest quality outcomes. As data is collected remotely from multiple sites in large volumes, having the technology to identify patterns and evaluate outliers as potential risks can help provide the proper levels of analysis and enable better collaboration. It is also important to consider regulations for computer system validation to ensure data integrity and that the system is fit for purpose. Centralized monitoring allows limits and risk importance to evolve over the course of a study and can highlight the impact of site-level differences on data outcomes as affected by staff training and compliance, so the technological capabilities should also support these analyses.
Centralized monitoring enables clear prioritization of critical data for monitoring to observe and analyze performance metrics, complete remote verification of the source data, and make administrative and regulatory tasks more efficient in terms of time, cost, and quality. Consider how it can be integrated with current monitoring processes to better optimize the use of resources and improve the quality and safety of clinical trials.
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Contributions by Courtney Loughran