Risk Based Monitoring is a term that is not new to the pharmaceutical industry. With increasing demand for budget reduction and reduced time to submission in drug development, both sponsors and vendors are seeking ways to reduce costs whilst still maintaining and potentially improving the quality of the data collected in clinical trials. Study costs can rise considerably for clinical trials with a large number of sites, especially across multiple countries. Risk Based Monitoring can reduce study costs considerably as there is a reduction in the need for CRAs to travel to sites, especially when coupled with a remote monitoring component. Also a reduction in the need to monitor all clinical trial sites and 100% of trial data, as those which are identified as more risk prone are visited more frequently according to targeted or triggered formulas. Even the FDA understands and encourages the desire to move away from 100% source data verification. Why therefore is the general mind-set in clinical operations exhibiting a degree of inertia to change with regard to RBM techniques?
The infographic below presents survey data that indicates the increase in the use of risk based monitoring and how data from trials using RBM solutions has now risen from previous years.