July 23, 2018

New Guidance for Multiregional Clinical Trials

The FDA has issued new guidelines designed to help researchers navigate sometimes conflicting regional requirements and differences in global clinical trials in an effort to pave the way for better cooperation and faster international drug development.

The Pulse

Patient Centricity: A positive shift for the patient experience

Sponsors’ heightened awareness of the importance of patient engagement in the design and execution of research studies has led to the discovery of crucial information about participation pain points. The information often reveals huge disconnects in what patients prefer and what they experience. Resolving these disconnects can have a significantly positive impact on patient recruitment.