More than half of the top 50 pharma sponsors have had to make protocol changes in their ongoing trials since the COVID-19 pandemic began, driving up volume at IRBs and sparking “remarkable growth” in clinical trials over the past three months. Read More

The issues posed by the COVID-19 pandemic have led to a roughly 30 percent increase in site costs, with much of the increase stemming from sites being forced to quickly adopt remote monitoring and other measures in response to the crisis, experts say. Read More

As clinical trials grow more complex and technology offers more ways to acquire and process the data generated during studies, researchers face a growing tension between providing data for evaluation quickly — often with goals of near-real-time — and ensuring that it is accurate and free from anomalies. Read More

New recommendations for the collection, reporting, management and analysis of patient experience data to be used in trial design are outlined in a final guidance the FDA released last week. Read More