Keys To Successful Blinded Labeling

By Beth Baxter, Singota Solutions

Blinded labeling is an essential element in all clinical trials. To remove the risk of bias, active pharmaceutical ingredient (API) drugs, delivery apparatus, and kits must be visually indistinguishable from placebo units — including their respective labels. The content and creation of these labels, though, is tightly regulated and benefits from the guidance of an experienced partner.

Sponsors must provide a blinded product for Phase 1B clinical trials and all subsequent trials. API and placebo labels’ content is determined by regulations in the nations hosting each trial site, but typically, each label shows: a batch number, a caution statement (indicating the unit is for clinical trial use only), a child warning (if the unit is for at-home use), storage conditions, and manner of administration. Some countries also require an expiration date or a retest date on the label, as well as emergency contact information.

The earlier an organization engages a blinded labeling partner, the better. Earlier engagement allows the label maker more time to work out details and review documentation, including batch records.