Unblinding Risk in Clinical Trials 

Sponsor organisations often conduct trials that are, and must be, blinded. To avoid bias when interpreting clinical trial data in blinded studies, sponsor representatives should not become aware as to whether subjects have received placebo or active medication.

If something occurs that has the potential for identifying placebo or active, how does the sponsor provide oversight without becoming unblinded?

JWQC personnel have acted as the sponsor’s unblinded representatives, providing QP and GMP expertise to independently check documentation associated with IMP manufacture, packaging and testing that would otherwise unblind the sponsor. We provide feedback to the sponsor in such a way as to maintain the blind.

Our manufacturing experience helped us to identify a situation where the compiling of information from certificates and labels into a document could have led to unblinding. Removal of the document and working directly with the IMP manufacturer to investigate and risk assess the event, helped to prevent the unblinding situation from occurring. Updated master batch records were produced at the CMO, with additional controls to address the potential unblinding issues. The associated trial continued safe in the knowledge that the risk to unblinding had been reduced.