Developing cost effective new drugs and therapies is a major challenge for life science industry. Drug development involves a number of phases among which the clinical trial management phase is the most complex one. It needs planning, execution and monitoring of clinical trials to obtain reliable study data for regulatory submissions. However, in the clinical trial management, one of the major costs owes to the clinical monitoring. Studies have revealed that conducting frequent monitoring visits to investigational sites and 100% source data verification (SDV)through traditional ways don’t always lead to high data quality. This calls for a smarter and better approach for more efficient study data monitoring. A number of monitoring approaches have evolved these days but the centralized monitoring has been proved to be the most effective approach for improving patient safety and data quality in a cost effective manner. Many regulatory bodies, including FDA, encourage the use of centralized monitoring.
What is Centralized Monitoring?
Centralized monitoring refers to the remote evaluation of data conducted by a team that includes central monitors and medical reviewers. The team is based at a location other that the clinical investigation site. Clinical analytical technology and electronic data capture tools have made the remote monitoring of study data and tracking of issues and risks easier. However, it’s important to understand and implement centralized monitoring in the right way to maximize its benefits. Successful implementation requires the right technology, effective planning, cross-functional expertise alignment and process restructuring.
Advantages of Centralized Monitoring
Centralized monitoring offers myriad of benefits such as:
- Better monitoring of patient safety which leads to enhanced subject protection.
- Early identification and mitigation of issues and risks associated with data quality that may interfere with the validity of study results.
- Enhances the efficiency of Clinical Research Associates (CRAs) and helps in better time utilization during on-site monitoring
- Increases overall efficiency in clinical trial operations
- Optimization of on-site monitoring visits and related cost
- Better planning of on-site visits through tracking of site performances
Technology Involved in Centralized Monitoring
For implementing centralized monitoring, it’s important to employ the right technology and ensure that the study data is in the right format and can be monitored in a timely manner remotely. Effective centralized monitoring also requires integration of operational and clinical data from different sources like IRT, CTMS, EDC and e-diary. Right combination of technologies is crucial so that the system can handle the required data volumes. Additionally, the right analytical, collaborative and visualization tools are necessary for making the process more reliable, efficient and innovative. Analytical tools help in identifying risks associated with patient recruitment rate and patient screening failure. They also help in identifying non-performing sites. It’s advisable to use a powerful technology that can apply statistical approach to data for determining protocol deviations, data quality issues, AE/SAE rates etc. To make the centralized monitoring beneficial, it’s important to regularly monitor the metrics associated with timelines, quality and budget. This would help in obtaining a good understanding of how to develop an optimized centralized monitoring process that ensures cost effective and better results.