Are We Ready to Adopt a New Approach To Run Clinical Trials?

By Lauren Garson

COVID-19 has put a spotlight on how the industry runs clinical trials, with the pandemic forcing “hundreds of clinical trials to grind to a halt” per an NPR analysis of federal clinical trials data. ¹ Since many new and existing studies are not actively enrolling subjects, and monitors are unable to conduct onsite monitoring visits, the industry has the opportunity in the upcoming months to design more efficient ways of managing and monitoring clinical trials.

Are 4-6 week regular interval onsite monitoring schedules and 100% source data verification (SDV) effective? Or can more monitoring tasks be done remotely, with a focus on at-risk sites while still ensuring patient safety and improving data quality? Should the role of the monitor change? We have been asking these questions for years – since regulatory bodies introduced the idea of risk-based monitoring (RBM) – but they are even more relevant today as the industry considers the design of post-COVID-19 monitoring plans and seeks to optimize the way clinical trials are managed.