Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees

By Bart Cobert

This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients.

The issue here is the breaking of the blind on individual patients in clinical trials for the purpose of submitting an expedited (15 or 7 day) report to FDA, EU member states and other health agencies.

Let’s first review the background and the regulatory requirements for unblinding.