In an effort to help ensure patient safety and alleviate strain on healthcare resources during the COVID-19 pandemic, Astellas is implementing changes to our clinical trial operations.
In countries with rapid growth of new COVID-19 cases, Astellas is suspending start-up activities involving study sites for new interventional clinical studies. We are also suspending enrollment of new patients in ongoing studies. In countries no longer experiencing rapid COVID-19 case growth, we are resuming or continuing study activities.
Consistent with recently issued guidance from US and EU regulatory bodies, Astellas is assessing protocols and implementing measures to reduce the burden to healthcare systems while ensuring that patient safety can be maintained.
We will frequently reassess this approach, which applies to all interventional clinical trials led by Astellas and its subsidiaries and affiliates. Some clinical trials led by our collaboration partners may implement a different approach.
Astellas remains focused on protecting patients, employees and our business, while maintaining regulatory compliance and data integrity across clinical development programs. As hospitals and clinics address the needs stemming from the COVID-19 pandemic, it is important that resources be focused on that challenge.
