Companies rarely broke the blind – the usual reason when this was done was for immediate treatment of the patient in an emergency situation. Let’s first review the background and the regulatory requirements for unblinding.įor many years after the concept of expedited or alert reports (or as FDA calls them, IND safety reports) of individual cases was introduced, the agencies accepted blinded reports. 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. 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.
0 Comments
Leave a Reply. |