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

COVID-19 has put a spotlight on how the industry runs clinical trials, with the pandemic forcing more than 3,400 trials to shut down. 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.

Research shows that 100% SDV “does not guarantee error-free results and concentration on transcription accuracy does not guarantee data quality.” 2 Only 1.1% of all eCRF data is corrected by SDV, 3 yet SDV accounts for 34% of a phase III study budget. 4 Focusing more resources and effort on value-added activities and less time on-site will be beneficial for the industry.

COVID-19 has accelerated the need for more remote work opportunities to ensure clinical trials can continue to treat patients, even during challenging times. Remote monitoring, centralized monitoring, and risk-based monitoring are viable solutions. RBM enables sponsors and CROs to identify high-risk activities and assess risks so that monitors can visit sites less often. When monitors do conduct an on-site visit, they can work more efficiently and only focus on those high-risk areas.

Clinical teams should identify efficacy and patient safety risks upfront during the study planning process to design the study with those risks in mind. This requires a risk-based approach and an organizational commitment to adopting new ways of working.

COVID-19 has highlighted the need for a new normal with respect to clinical trial monitoring approaches – and now is the time to take action and drive change. Stay tuned for the next blog in our series, where we’ll explore what the monitor’s role should look like in a post-COVID-19 era.