The Rise Of Risk-Based Monitoring In The Clinical Trial Landscape

In 1948, UK scientists conducted the first randomized controlled trial (RCT), investigating the use of streptomycin to treat pulmonary tuberculosis. The introduction of randomization into clinical studies is noted as one of the first steps toward the modernization of clinical research. Fast forward to the present, and the clinical trial industry has experienced continuous innovation – from the WHO’s Good Clinical Practice (GCP) guidelines in 1995 to the decentralized and remote monitoring solutions of today.

One of these recent revolutionary discoveries is the application of Risk-Based Monitoring (RBM), clinical trial monitoring that applies risk assessments to study data to adjust mitigation strategies on an on-going basis for the duration of the study. While the guidelines for RBM were established by the FDA in 2013, acceptance of RBM has since expanded internationally across the clinical research community.

RBM has gained greater significance since 2019, as clinical trial management wrestles with stoppages and delays due to the COVID-19 pandemic. Those looking to incorporate RBM into trial strategies should understand that this methodology requires prior due diligence – a better understanding of how to engage with RBM for short and long-term goals – in order to realize the inherent benefits.