The COVID-19 pandemic has washed over the world in waves and affected every aspect of life, including most obviously, healthcare. The impact is not only seen in relation to coronavirus patients and studies, but the ripple effect is also seen across all clinical and real-world studies. Several key factors have disrupted research efforts, including shelter-at-home mandates, limited access to healthcare facilities, patients’ comfort level in participating in studies, and the shift in priorities and capacity of healthcare providers.
These types of disruptions lead to some key challenges. For example, patients cannot visit sites to have their standard of care or protocol-defined safety assessments performed; patients’ ability to visit sites for clinical or patient-reported outcome assessments are hindered; and there is a decrease in patient recruitment and retention rates. Patient safety is always the main priority of our industry, and we also need to continue to collect study dictated data as much as possible. To do this, we need to figure out ways to ensure patient safety in the current global scenario and mitigate the impact on study disruption.