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Centralized Monitoring in a New Age of Clinical Trials

what is centralized monitoring?
what is centralized monitoring?

What is Centralized Monitoring?

Centralized monitoring is the process of collecting data from multiple sources, such as multiple research sites or across patient populations, to a remote, central location that is located away from the sites.

This data is then evaluated by teams that can include clinical monitors, data managers, and statisticians.

Centralized monitoring has been used increasingly over the past decade as clinical research has been reshaped by increased data sets and the need for collaboration between sponsors and CROs regarding monitoring plans, and the use of new technologies to facilitate the same.

What Advantages Does Centralized Monitoring Bring?

Centralized monitoring began with some potential benefits in mind. It allowed for all the source data to be collected in one electronic system that could be accessed and monitored remotely.

This has led to a clear set of benefits:

  • Increased efficiency through decreased visits for source data verification (SDV), real time monitoring of trial status, data quality, and compliance with regulatory requirements.
  • Increased efficiency for risk based monitoring through real time identification of risks to patients, outliers, and trend identification.
  • Increased ability to implement adaptive trial monitoring because of the availability of near real time data.
  • Increased efficiency in data management through use of digital source data.
  • Increased validity of research through the ability to use expanded data sets or involve more research sites without prohibitively increasing costs.
  • Monitoring of sites across data sources (such as logs and metrics, CDx (Companion Diagnostic) data, NGS (Next-Generation Sequencing) data, etc.)
  • Decreased costs associated with less frequent onsite visits by monitors.

While these benefits had been evident for some time, the real advantage was seen during the COVID-19 Pandemic, when travel bans and social distancing rules forced the need to implement centralized monitoring for many multi-center clinical trials.

What are the Barriers of Centralized Monitoring?

Centralized monitoring has proven to be a method of increasing efficiency and decreasing costs, while increasing the quality and validity of the research being performed. However, it cannot mitigate all the risks involved in multi-center research.

Onsite visits are still required for several tasks, including:

  • Training of on-site staff.
  • Investigational product accountability (such as counting the investigational drugs and ensuring proper storage).
  • Follow up on queries regarding source data.
  • Ensuring on-site compliance with protocol.

Conclusion

Centralized monitoring, the tools used in its implementation, and the risk mitigation strategies employed have strengthened significantly over the past decade.

Despite the clear benefits involving increased efficiency and decreased costs, centralized monitoring requires critical thinking, prediction of potential risks and their key indicators, and upfront planning of strategies for the same.

However, through proper training, standardization and streamlining of processes, use of the appropriate software, predictive and advanced analytics, and collaborative and open communication between the central monitoring teams and on-site staff, coupled with onsite visits using adaptive monitoring, the benefits and risks can be ideally balanced.

With all that has been learned and modified in the central monitoring process, even in times of global emergencies these strategies can be used to successfully and efficiently run clinical trials across multiple sites.

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