In anticipation of my Risk Based Trial Monitoring: A Technology-Amplified Approach webcast presentation (February 28), I wanted to hone in on site monitoring.

Site monitoring has traditionally been one of the most expensive aspects of conducting clinical trials. Costs of site monitoring have been estimated to be 25% to 30% of the overall costs of a clinical trial.1 The high cost is in large part due to a traditional approach of having site monitors travel to individual sites on a time interval basis to collect and review data, whether or not there is sufficient workload on-site to warrant a visit. As electronic data capture replaces hard case report forms, monitors are able to review data remotely. Technology now also gives visibility to other key operational data points that can drive decisions about when an on-site visit is required.  This results in several benefits.

Fewer site visits. With electronic data capture and data visibility, site monitors are able to review data collection in real time and determine which sites are performing well according to the study plan, and which sites need more management and focus. This can change how site visits are scheduled, from visits at set intervals, such as every eight weeks, to event-driven visits. Widely known as “adaptive” or “risk-based” monitoring, this approach involves the use of real time data to initiate a site visit when it is justified by on-site workload or quality signals such as enrollment, query management, protocol deviations, safety issues, staff transition and others. Risk-based Monitoring minimizes wasted time and effort by scaling monitoring activities and visits based on actual data collected during the study and any quality indicators that require on-site attention.

Reduced costs. The reduced visit frequency significantly reduces the direct cost of monitoring, particularly for global trials, as monitors schedule site visits based on data-driven need and patient accrual.  At its full maturity, this model has the potential to reduce site visits by up to 75% without sacrificing data quality or safety.

  • More strategic visits. Visibility to data between site visits means the monitor is able to address issues specific to a site, whether remotely or by triggering and on-site visit. For example, the monitor can assess questions such as
    • Is the site conducting the study according to the project plan?
    • Does the site need more training in the e-monitoring system or the protocol?
    • Does the site seem to have a higher or lower number of adverse events, protocol deviations, queries or subject discontinuations than expected?
    • Does the site have an inordinate lag in data entry into the eCRF, or is the site showing a significant number of data changes in the system?
    • Time saved. Eliminating manual tracking results in a substantial amount of time saved, and that time can be better used towards value added tasks, such as remote monitoring, query resolution, regulatory document maintenance, and overall site communication and relationship management.
    • Greater job satisfaction. Monitors have many different tasks and can feel pulled in several directions, resulting in long-term stress and burnout. With tools to make monitors’ work more efficient, their job satisfaction can increase, which in turn may reduce the likelihood of turnover.2

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1. Eisenstein EL, Lemons PW II, Tardiff BE, Schulman KA, Jolly MK, Califf RM. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J. 2005;149:482-488.

2. Bommireddy S. Reducing Turnover at Clinical Research Sites. Forte Research Systems. Accessed Jan. 30, 2013.