Centralized monitoring can be hugely beneficial for clinical trial effectiveness, especially in an age where more and more trials are utilizing technology and becoming more geographically dispersed. Optimizing for efficiency, ensuring cost-effectiveness, and safeguarding the integrity of data are all crucial elements of a clinical trial.
While traditional onsite monitoring has long been the cornerstone of ensuring data accuracy and patient safety, technology and data analytics have made it possible to take a more effective approach. And that is what we know as centralized monitoring.
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What is centralized monitoring in clinical trials?
Centralized monitoring, often referred to as central monitoring, is where data is collected from several clinical trial sources from a remote, central location. With the clinical trial landscape continuing to evolve, centralized monitoring has been designed to enhance data quality monitoring in remote and multi-site trials, while also addressing the complexities of these types of trials.
Often classed as a more risk-based approach, centralized monitoring has become a growing trend over the last ten years in response to increased data sets and a deeper need for collaboration, complex monitoring plans, and innovative technology to monitor modern trials. Its key objective is to supplement or reduce the need for on-site monitoring, but it can also help sponsors identify high-risk trial sites.
The FDA defines centralized monitoring as “a remote evaluation carried out by sponsor personnel or representatives (e.g., clinical monitors, data management personnel, or statisticians) at a location other than the sites at which the clinical investigation is being conducted”. The FDA also strongly advocates for the use of centralized monitoring wherever possible and appropriate.
A key aspect of centralized monitoring is enabling data to be reviewed and assessed for quality, with a strong focus on addressing minor or inconsistent entries, outliers, or protocol deviations. Sponsors can analyze data sets and seek out trends in several metrics, including consistency, distribution, and completeness. This enables them to identify discrepancies in how protocols are being adhered to across sites or other contexts to establish whether intervention is needed.
Sponsors can also be used to remotely monitor performance metrics, verify source data, and add more value to the trial, without relying on on-site monitoring which can be time-consuming and inaccurate.
Benefits of centralized monitoring in clinical trials
Using centralized monitoring in clinical trials offers several different benefits for professionals seeking to enhance the efficiency, quality, and overall success of a study.
Improved data quality and integrity
Centralized monitoring is one of the most effective ways to improve data quality and integrity. In fact, the FDA believes that centralized monitoring can identify nearly 90% of on-site monitoring findings. This monitoring method allows for consistent and real-time data review, ensuring greater data accuracy across all trial sites.
It also enables sponsors to detect data issues early and quickly identify anomalies, trends, and potential errors so that corrective actions can be taken. This is key because it can help decrease the time to marketing approval and result in higher quality regulatory submissions.
Enhanced efficiency
With less need for frequent site visits for source data verification, centralized monitoring can save on resources and enhance the efficiency of the trial by analyzing data centrally. This is hugely beneficial in terms of both time and cost for trials that occupy several sites, especially on an international level. Centralized monitoring also facilitates quicker data processing and decision-making, speeding up the overall timeline of the trial.
Enabled risk-based monitoring (RBM)
Centralized monitoring is a key enabler of risk-based monitoring (RBM), where trial resources are allocated based on identified risks. This enhances the focus on critical data and processes, improving the overall outcomes of the trial. With a shift to electronic data capture and more efficient data management, centralized monitoring can also be used in adaptive strategies, improving the responsiveness and adaptability of the study.
Enhanced compliance and reporting
Regulatory requirements and compliance are key priorities in clinical research, and centralized monitoring can enhance this compliance by ensuring adherence through comprehensive and real-time audit trails. It can also improve documentation by enabling professionals to create robust documentation and reports essential for regulatory submissions and inspections.
Cost-effectiveness
Centralized monitoring can help sponsors and clinical trial organizers to save money, in terms of both resources and operationally. With a reduction in on-site visits and associated travel expenses, operational costs are lower. By optimizing the use of monitoring resources, centralized monitoring can also focus efforts where they are needed the most.
Better communication and collaboration
The technology used in centralized monitoring can improve communication and collaboration in a clinical trial, across teams internally and multiple sites. With one single platform for data access and review, communication between sponsors, CROs, and study sites is improved and there is one single source of the truth. Additionally, there is a continuous data flow and updates which enables all stakeholders to stay informed and aligned on the progress of the trial.
Enhanced patient safety
With greater access to data in real-time, patient safety can be improved too. Researchers are able to detect adverse events or protocol deviations early, ensuring timely interventions that can protect patient safety. Centralized monitoring also enables comprehensive oversight, with a holistic view of patient data across all sites. This can support better management of patient safety and trial integrity.
Easier data integration and analysis
Centralized monitoring can quickly and effectively integrate data from multiple sources, providing a comprehensive view of trial data. This holistic data view enables better analysis and decision-making for research teams. With one centralized system, advanced analytics and data visualization tools are often available, helping researchers identify patterns and insights that could be missed with traditional monitoring.
Challenges of central monitoring in clinical trials
As with any type of monitoring in a clinical trial, there are always challenges in addition to benefits. Centralized monitoring in clinical trials can present several significant challenges and overcoming them often requires careful planning, robust infrastructure, effective change management strategies, and comprehensive team training.
Data integration and standardization
Where clinical trials have multiple data sources, integrating and standardizing the data can be complex and time-consuming. This is especially true when different sites use different methods, such as electronic data capture (EDC) and electronic health records (EHR). When transferring data from EHR to EDC, one of the key challenges is duplicated data and the time it takes to manually check and enter data.
Maintaining data quality and addressing discrepancies remotely is often more challenging than on-site reviews.
However, several tools are now available to help combat this challenge. For example, some tools have been designed to present matches in EHR data for an EDC form, enabling much quicker completion of forms when compared to manual data entry.
Compatibility and scalability
With plenty of technological infrastructure needed to ensure centralized monitoring can be beneficial and work as it should, ensuring compatibility and scalability are key factors to consider. As trials continue to grow in size and complexity, it can be challenging for trial organizers to fund the initial investment needed for technology and subsequent training.
Coupled with ongoing maintenance costs, it can be significantly costly to implement centralized monitoring in a way that ensures compatibility and scalability.
Data security and regulatory compliance
Another challenge of centralized monitoring, as well as with other types of clinical trial monitoring, is ensuring data security and regulatory compliance. Clinical trials are highly regulated, and data security and privacy of participants need to be rigorously maintained throughout the trial to comply with regulations like GDPR and HIPAA, especially in international trials.
Trial organizers must ensure regulatory and ethical considerations are key priorities when implementing centralized monitoring. This includes transparent practices and robust documentation to ensure compliance and safety. Centralized monitoring makes this easier with the ability to keep everything in one place.
Human resources and communication challenges
Resource management is often challenging in clinical trials and implementing centralized monitoring is no different. Human resource challenges include ensuring staff have correct training on new procedures and new technologies, as well as overcoming resistance to change from sites that are used to traditional monitoring methods.
As well as resource issues, centralized monitoring can also impact communication if not managed appropriately. Trial organizers should ensure a clear plan is in place to maintain effective communication and coordination between centralized teams and site staff. This is crucial for centralized monitoring and ensuring issues can be addressed quickly.
Implementing risk-based monitoring
If risk-based monitoring is also a part of a centralized monitoring strategy, this can pose a challenge to clinical trials. Implementing risk-based monitoring requires organizers to define clear risk parameters and adapt the monitoring plans as needed, which can be significantly tricky, especially in trials taking place on an international scale.
On-site monitoring vs. centralized monitoring: which is safer?
Both on-site and centralized monitoring come with benefits and drawbacks, so establishing which method is the safest is a topic up for debate.
On-site monitoring allows researchers to observe the participants and their environment directly, which can support the quick identification and resolution of any issues that could crop up. However, this more traditional method can also involve frequent travel, higher costs, and the potential for human error.
Centralized monitoring reduces this need for travel and the possibility of human error, but relies on remote data review and analysis. While beneficial in many aspects, this may not provide the same level of close oversight that on-site monitoring can provide.
Research teams should consider both methods carefully, establishing the goals and requirements of the study in question before making a decision. Ultimately, the level of safety each method delivers depends on the trial. It’s even possible to use a combination of both approaches to ensure higher levels of safety and the most effective trial outcomes.
Conclusion
Centralized monitoring can deliver several benefits to clinical trials, leveraging technology and advanced data analytics to provide continuous, real-time oversight of clinical trials. With this in mind, centralized monitoring can improve efficiency, data quality, and patient safety while reducing the need for extensive and frequent on-site visits.
Clinical research is advancing at a rapid pace and modern technology is being implemented in almost every aspect of a clinical trial. Therefore, centralized monitoring aligns with the wider clinical trial landscape and the approach toward more data-driven, efficient, and patient-centric clinical research practices.
FAQs
What is remote monitoring in clinical trials?
Remote monitoring in clinical trials is where participant data is collected and analyzed without physical visits to the trial site. This can include using technology such as remote sensors, wearable devices, or virtual communications tools that capture and send data.
What is risk-based monitoring in clinical research?
Risk-based monitoring (RBM) is a method of clinical research monitoring that places an emphasis on identifying and mitigating potential risks in a trial. It takes a more targeted approach, allocating resources based on the level of risk associated with various elements of the study. RBM also focuses on data quality and integrity so that potential risks to these aspects can be identified and addressed early on.
What is statistical monitoring in clinical trials?
Statistical monitoring is another method of monitoring where data is continuously analyzed and monitored throughout the trial to ensure the safety and efficacy of the treatment being tested. Researchers might use statistical tools and methods to track any potential issues or trends that could occur, such as unexpected outcomes or adverse side effects.
What are decentralized clinical trials (DCTs)?
Decentralized clinical trials use digital technologies and remote methodologies to conduct clinical trial activities. This minimizes the need for participants to visit centralized study locations. Researchers may use telemedicine, mobile health apps, wearable devices, and home visits by mobile nurses to collect and monitor data.