Centralised Monitoring: A Smart and Cost-efficient Approach

The clinical monitoring cost is one of the major costs, accounting for one-third of the overall cost, of clinical trial management. As complexities in clinical trials have increased significantly in the last few years, the clinical monitoring cost and in turn the trial management cost has increased immensely in order to achieve higher data quality and better monitoring of patient safety. However, traditional ways of conducting frequent monitoring visits every 4-8 weeks to investigational sites and 100% source data verification do not necessarily result in higher data quality, better patient safety, or in an understanding of the critical issues early in the process. Therefore, it is essential to look into alternative, intelligent and smarter ways to achieve improved data quality and patient safety in a cost-effective way. Considering innovative monitoring approaches, centralised monitoring appears to be the most suitable approach available today to proactively identify risks to data quality, and patient safety, in a cost‐efficient manner.

Centralised Monitoring: A Smart and Cost-efficient ApproachThe FDA guidance for industry "Oversight of Clinical Investigations –A Risk Based Approach to Monitoring", finalized in August 2013, states that the focus for clinical trials is now on critical data and advocates the use of a number of monitoring activities, but encourages greater reliance on centralised monitoring practices where appropriate. This view is echoed by the EMA and the Competent Authorities in Europe. Therefore, there is no doubt that there will be a considerable impact on the monitoring of clinical trials in the near future.

The FDA guidance document states that centralized monitoring is "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".

Centralised monitoring processes can provide many of the capabilities of on-site monitoring as well as additional capabilities. With the advent of eCRFs (electronic case record forms) and other eDCT (electronic data capture tools) it is easy to check things centrally or remotely.

The right implementation of a centralised monitoring approach is essential in maximizing benefits with regard to higher quality of study conduct, reporting and better monitoring of patient safety with a reduced number of on-site monitoring visits. The successful implementation of centralised monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place. Designing realistic efficient monitoring plans with pre-defined risk indicators, thresholds with suggested action plans, training of resource, selection and validation of analytical tools are important aspects of adopting a centralised monitoring approach.

Many organizations are still developing and standardizing their centralised monitoring process together with its evaluation and the integration of current key processes such as data collection, cleaning and monitoring. With the appropriate system, process and trained resources, centralised monitoring is an effective tool to meet the growing challenge of ensuring that the study protocol is being correctly interpreted and executed, resulting in effective patient care and valid study results whilst simultaneously reducing clinical trial costs. Sumber  Zona Information

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