Centralized Monitoring: A Smart Solution For "Oversight"

By Ashok Ghone, Ph.D., Vice President, global services, MakroCare USA

As clinical trial management costs rise because of increasingly complex protocols and stringent regulatory requirements, it has become important to have proper oversight of clinical trials, programs, or projects to avoid any major setbacks and to ensure the achievement of required quality, expected timelines, and return of investment (ROI). Centralized monitoring, if customized and planned properly using the right technology, offers a smart solution for “oversight” of a trial/ program to ensure compliance to protocol and regulatory requirements and to control, mitigate risk/issue(s) on time.

The success of this approach broadly depends on:

• Development of an appropriate “Oversight” plan for a clinical trial or program: The “Oversight” plan should highlight key risk areas or critical success factors that one wants to monitor through the oversight process. It should explain areas to be monitored like quality, safety, timelines/efficiencies, resources, vendors, or financials for the oversight purpose. The plan also provides details about the data required, sources of the data used, and metrics that need to be monitored to enable complete oversight of the relevant area planned. Some of the challenges while developing oversight plans are identifying the right data and getting real time access to that data to get the required timely reports for the oversight purpose. The use of right, robust technology, especially analytical and visualization tools to generate required metrics/reports for oversight purposes, will be a key part of an oversight plan.
• Identification of the right metrics upfront which will facilitate oversight of different areas through centralized monitoring: Depending on the area of oversight, whether it is quality, safety, timelines/efficiency, or budgetary, one has to identify the key metrics to be monitored which will allow easy assessment of performance and identification of risk/issue(s) related to the area. The metrics results should also help to plan corrective and preventive actions to ensure the achievement of critical success factors. As far as number of metrics or reports to be followed, it is also essential to keep the number at the optimal level, while at the same time allowing smooth as well as complete oversight of the performance. The frequency of generating metrics results or reports is also important to ensure proper and complete oversight of a trial/program. The comparison of metrics results obtained at different time intervals, such as on a monthly or quarterly basis, should be used effectively to monitor new strategies or corrective actions planned for the improvement.
• Access to the right data which will help in generating required metrics: The key is to use the right data from different sources which will provide the relevant and proper metrics to ensure clear and easy oversight. One of the challenges here is to get real-time access to the data collected during conduct of clinical trials by different discrete systems, such as EDC (electronic data capture), IRT ( Interactive Randomization Tool), CTMS (Clinical Trial Management System), e-diary,  or safety and other central laboratory data which might be under control of some other third party vendor where direct integration with their systems may not be possible. This will lead to issues in getting the data for analytical and visualization tools to generate required reports on a timely basis. The other challenge is the data might not be available on time (e.g. delayed data entry by sites in EDC), even though there is smooth access to the system.
• Use of robust technology (analytics) that will generate the reports or required metrics: It is necessary to have technology in place that can streamline the collection of data, handle required data volume, and visualize planned oversight reports on a real-time basis which can be easy to interpret to assess performance or monitor risk/issue(s) related to quality, safety, team/vendor performance, and timeline. In general, the technology should be user-friendly and be able to identify trends, patterns, and outliers to assess performance at the program, protocol, or site level for oversight purpose. It should help in integrating appropriate methodologies and data sources for analysis.

Some of the examples of metrics that can be used for “Oversight” purposes include:

Centralized Monitoring can be effectively used for “Oversight” of:

• Critical risk areas and critical success factors
• Clinical investigations and investigational sites’ performances
• Subject safety aspects (study drug-related safety issues, number of drop-outs due to AEs/SAEs, etc.)
• Internal and external (CRO/Vendor) team performances and efficiencies, SLA ( Service Level Agreement) management
• Protocol and regulatory compliance
• Implementation of key strategies and their outcomes
• Overall quality, timeline  achievements, and budgetary spending

Centralized monitoring, if used tactfully, offers a smart and effective solution for “Oversight” purpose which helps in the real-time assessment of quality, timelines, vendor/CRO performance, and budget. The approach is helpful in proactively controlling, mitigating any risk/issue(s), implementing timely, key decisions related to the study, resources, and budget, and it also is useful in creating overall efficiencies in trial/project operations to ensure ROI.