The Future Of Clinical Monitoring

In transitioning to more remote monitoring services out of necessity during COVID-19, the industry is realizing the potential to update how monitoring is routinely performed in the oversight of clinical trials. The pandemic's impact on site availability and accessibility for patients and clinical research associates (CRAs) emphasizes the importance of evolving monitoring methodologies going beyond the industry-wide dependence on the in-person review of work performed at clinical research sites with the intent to identify mistakes and correct them. A fundamental shift in approach is needed to increase efficiency and effectiveness of clinical monitoring, continuing to ensure overall study quality and patient safety while relying more on automation and predictive analytics to continuously evaluate progress, remotely.

Though there has been a growing interest from sponsors in the integration of remote monitoring in trial programs, updating historically utilized monitoring approaches has progressed slowly and in some cases, with skepticism. COVID-19 did not offer sponsors and the industry an opportunity to hesitate. With the support of regulatory agencies, there was a stronger push to leverage remote monitoring capabilities. Remote monitoring was critical to the clinical trial continuity response to COVID-19, enabling remote data monitoring strategies to address reduced site availability, CRA mobility issues and on-site visit restrictions for patients.

The shift in approach from on-site review to identify errors and fix them at each site to embracing continuous proactive surveillance of critical data and predictive statistical methods to identify potential problems and intervene before they manifest and propagate is the essence of modern risk-based monitoring (RBM) approaches featuring centralized clinical monitoring.