Virtual Trials and COVID-19: Ensuring Patient Safety and Data Quality

<p><strong>Speaking from a general safety perspective, as well as a cardiac safety perspective, what challenges have you observed in clinical trials resulting from the COVID-19 pandemic? [3:07]</strong></p><p>I speak for myself and others, no one trained us for this and we had to quickly react. We want to ensure the safety of the participant as well as making sure the data is right. We have to consider what is in the best interest of the patient and how we can ensure that the data that is collected will be able to be analyzed at the end of the study. We had to rethink what to do, but the situation differs. For a company in Phase I with very little information, it’s not the same as a Phase IV clinical study. However, the common ground is that they try their best to maintain the integrity of the trial. In particular with cardiac safety, there are certain parts of the clinical trial where remote monitoring can continue to be done.</p><p><strong>What approaches have you seen employed in ma...