Evolution of Clinical Trial Labels

Clinical Trial labels have evolved over time to accommodate changing clinical trial material (CTM) containers, as well as packaging and storage environments. Today’s manufacturing equipment has also opened new opportunities for complex label designs. Regulatory agencies around the world each have their own ideas around what needs to be included on a label, or what parts of the packaging need to be labeled. Regardless of what is required, the following is an evolution of types of labels and the materials/components that have been used.

Single and Multi-Panel Labels (1970’s – Current)

Cheshire/Tape Strips/PS – Paper/Synthetic Materials – Low Temp/Cryo

Double Blinded Labels/Reports – To Blind both Patients and Dispensing Investigators from the drug information

Printed with Dot Matrix Printers – Carbon spotted pocket and then NCR pocket which would blind the drug information until cut open and peeled back, revealing the drug dispensed information. This blinding conceals the drug information, which is primarily necessary to view should there be an adverse effect to the drug. (Early 1970’s – Mid 1980’s) 

Laser/Thermal Printers – Labels printed and then a scratch-off label was applied to blind the drug information until scratched off, revealing the drug dispensed information. (Mid/Late 1980’s – Early 2010’s)

Single or Multi-Panel labels either laser or thermal printed with barcodes or patient numbers for use with IVRS (Interactive Voice Response Systems). When there is a need to unblind the patient, a phone call or scan can be performed that will take the investigator to a website/platform that will allow them to reveal the drug dispensed information. (Early 2000’s – Current)

Booklet (Expanded Content) Labels – For Multi-National, multi-lingual studies (Early 2000’s – Current)

Short Base for wrap-around on round or square cornered containers where more than one panel of the CTM is being labeled. This label configuration allows it to be wrapped around the container, without bunching or popping open of the seal/reseal section.

Full Base for Flat applications where one face/panel of the CTM is being labeled.

E-Labels – Concepts are currently being discussed and prototyped

Flexible Screens or Barcoded labels that when scanned takes you to a “platform/program” that provides the data necessary for languages, dosing instructions, unblinding, etc. Updating of information/data is easily accomplished on the back end. Currently, there is no set standard to follow and is substantially more expensive then labels that are being utilized today.

Timeline requests have become increasingly shorter as time to market is key to the end user. Updated equipment and lean/robust procedures in place, help to satisfy the customer’s needs and more importantly, get drug product into the hands of the patients whose lives could be bettered, or saved.

If you would like to find out more information regarding AWT’s current offerings, please reach out to Graig Daley at [email protected].

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