Centralized Monitoring--A Smart, Reliable Approach

Centralized monitoring is a remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted. Centralized monitoring process can provide many of the capabilities of on-site monitoring as well as additional capabilities. With the advent of electronic data capture tools and clinical analytic technology, it is becoming easier to monitor study data and track the risks or issues centrally or remotely. Even the regulators encourage greater reliance on centralized monitoring practices where appropriate to fulfill responsibilities of monitoring and for effective oversight of a study. The right understanding and implementation of a centralized monitoring approach is essential in maximizing benefits. The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place.

Importance of Centralized Monitoring in Current Practice

The studies have shown that traditional ways of conducting frequent monitoring visits, every 4-8 weeks and 100% source data verification do not necessarily result in higher data quality. Therefore, there is a need to develop a smarter and complementary approach to achieve effective study monitoring.

Considering the innovative monitoring approaches available today, centralized monitoring offers a “cost‐efficient” and “intelligent” monitoring solution, as long as we have the correct processes coupled with trained resources and technology in place.

Using the right technology and statistical monitoring techniques, centralized monitoring can help identify higher risk clinical sites, those sites with higher frequency of errors, protocol deviations or data anomalies. It also helps in the analysis of site characteristics or performance metrics. It assists  to identify efficacy and safety data trending such AE/SAE distribution and outliers and thus help in early identification and mitigation of data quality issues which may compromise the study results. Centralized monitoring if customized and planned properly using right technology offers a smart solution for “oversight” of a trial to ensure compliance to protocol, regulatory requirements. As the cost of clinical trial management is increasing, it is becoming utmost important to have proper oversight of clinical trials/programs to avoid any major setbacks and ensure achievements of  expected quality, timelines and budget. 

Centralized Monitoring Implementation

The key steps involved in centralized monitoring implementation are as follows:

• Identification & defining  key risks and their thresholds

• Desinging a comprehensive monitoring plan & relevant documentations

• Continuous monitoring  of risks or issues using the right technology

• Corrective action planning to manage/ mitigate identified risk/issue(s)

For efficient and effective centralized monitoring implementation, there needs to be a well-thought-out, comprehensive monitoring plan. One that explains in detail what aspects of data monitoring would be achieved through centralized monitoring. The plan will outline the procedure and timings for site contacts, or on-site monitoring visits based on critical issues identified. In the plan, the key risk indicators, thresholds and performance metrics will be identified upfront and tracked and monitored throughout the process. The regulators require a systematic approach to identify and justify the key risk indicators.

The monitoring plan also states

• the frequency and extent of centralized monitoring activities

• provides a well-designed template to report findings

• lists the team members involved and their roles and responsibilities

• communication and co-ordination between the centralized monitoring team and the different stake-holders for issue escalation & resolution

• and any specific training requirements for a centralized monitoring team.

The monitoring plan should have provision to make amendments based on new risks identified related to data, procedures, sites or overall operations.

Role of a Central Monitor

As it is a newer approach, it is important to ensure that we have right expertise and trained resources in the place to drive the process. The central monitors will spend a considerable amount of time monitoring the data remotely and reviewing reports, identifying the risk/ issue(s). They should have past experience in monitoring and a good knowledge of data management activities. They should have good communication, coordination, analytical skills, and apply critical thinking to identify trends and outliers, especially those risks related to data quality or patient safety.

Technology Requirements

As centralized monitoring requires checking of the data remotely, it is only possible with help of robust and cutting edge technology. As data is being collected in different, discrete sources, it is necessary to have the right technology in place that can integrate the different sources of data and handle large data volume. The technology should be user-friendly and be able to identify trends, patterns, and outliers, also to assess the data performance at a study or programme level, site or country  level. From the reporting and visualization perspective, the technology needs to have the capability to review and analyze the data and provide graphical and visual representations that can easily identify risks or issues. As the industry is moving towards newer monitoring approaches, the market has seen the advent of number of collaborative, analytic clinical tools to support remote tracking of risks or issues related to clinical trial operations or data quality. However, whichever system is used, the technology should have undergone a vigorous system validation process to ensure compliance with regulatory requirements, that the technology consistently meets its specification, and is therefore suitable for its intended purpose.

Many organizations are developing and standardizing their centralized monitoring process. Evaluating its integration with current key processes such as data collection, cleaning and monitoring. With the appropriate system, process and trained resources, centralized monitoring is an effective tool to ensure that the  protocol is being executed correctly, resulting in effective patient care and valid study results, whilst also reducing clinical trial costs. The monitoring of the metrics related to quality, safety, timelines and budget using a centralized monitoring approach will help understand the benefits and potential of centralized monitoring and will give further insight to the industry in developing processes, resources and technology to ensure better outcomes.

Ashok Ghone, PhD is Vice-President, Global Services at MakroCare USA. ashok.ghone@makrocare.com