P201: The Future Utilization of Digital Display Labeling in Clinical Supplies for Human Clinical Trials

Poster Presenter

Raj C Shah

Senior Specialist, Global Regulatory Affairs and Clinical Safety
Merck & Co., Inc.
United States

Objectives

Digital Display Labeling in Clinical Supply is currently being developed and can potentially bring efficiencies and modernize clinical trials while providing significant advantages to patients, clinical study personnel, health authorities, and sponsors.

Method

Digital display labeling in clinical supply has been in development for over a decade and has undergone several prototypes. Testing such as readability studies and patient focus groups have been performed to gain patient input and quantitative data evaluating digital labels versus paper labels.

Results

High level findings of the readability studies quantitatively proved that digital labels were equivalent to paper labels. However, the true benefits to patients, clinical trial investigators, and agencies are from the flexibility, increased information, and broadened use that digital labels provide. This includes performing GMP changes to labels such as editing expiration dates (allowing decreased relabeling burden and increased clinical trial efficiencies). A significant benefit of the labels is the opportunity to pool medication beyond the current possibilities of Just-in-time (JIT) labeling practices. This will further reduce the overages and discards of highly valuable investigational medication in clinical trials. Other benefits include the ability to change the language or other information on the label and contributing to an improved environmental footprint. Additional enhancements of the digital label are also being explored, such as scrolling between pages on the digital label.

Conclusion

While digital labels have been widely utilized in other industries, there is projected to be an increased presence of the technology in the pharmaceutical industry. Digital labels offer numerous benefits to patients, clinical trial investigators, and agencies including the ability to edit labels in a GMP controlled, efficient and safe process, with improved environmental sustainability and increased supply chain flexibility, as well as ease of use in different patient populations due to language adjustability. Additional benefits of the digital label are also being explored for implementation. This technology has been in development for several years and has undergone various prototypes for use in the clinical trial setting. Looking forward, increased testing on the final digital label prototype will be completed and used in human clinical trials.