Keywords: unblinding, bias, phase 1 trial
To Blind, or Not to Blind? That Is the Question! Many statisticians believe unblinding treatment assignment of any ongoing clinical trial should be strictly prohibited to avoid the introduction of bias. However, there are also statisticians advocate that properly unblinding certain personnel from the sponsor in phase 1 trials not only will not introduce bias but will enhance drug development process.
We would like to discuss and share experience in how or if sponsors remain blinded. There is a general belief by the sponsors that there is much to gain and little to lose in being unblinded in Phase 1 trials. Some of the advantages of unblinding include early direct assessment of treatment-related safety signals with the option to make appropriate trial design modifications and speeding up early drug development. What is the right approach to unblinding? Can the unblinded lead the blinded? How unblinded should work? We will discuss approaches to unblinding and pros/cons of either being very strict or liberal on unblinding.