Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience

Area of Science:

• Clinical Trials Management
• Pharmaceutical Logistics
• Health Informatics

Background:

• Efficient study drug inventory management is crucial for successful multisite clinical trials.
• Traditional manual drug management processes often fail to account for logistical complexities like import permits, transit times, and time zones.
• The Tuberculosis Trials Consortium (TBTC) and AIDS Clinical Trials Group (ACTG) faced challenges with their manual drug management system.

Purpose of the Study:

• To develop and evaluate a web-based Drug Management Module (DMM) to improve the efficiency of study drug inventory shipments in multisite clinical trials.
• To compare the DMM's performance against the traditional manual process in managing drug stock-outs and availability.

Main Methods:

• A technological solution, the DMM, was developed integrating logistical and regulatory requirements with statistical simulations for stock-out estimation.
• An Interrupted Time-Series (ITS) analysis was used to assess the impact of DMM implementation.
• Key metrics included average shipment-related drug stock-outs and time to drug availability.

Main Results:

• The DMM implementation resulted in a statistically significant 15.4% reduction in average shipment-related study drug stock-outs.
• The DMM streamlined restocking, reducing median transit time by 2 days for sites using a depot.
• Study drugs became available on the day of receipt under the DMM, compared to one day after receipt with the manual process.

Conclusions:

• The DMM offers a more efficient procedure for managing and maintaining study drug inventory at clinical trial sites.
• This DMM framework has the potential to enhance efficiency in future multicenter clinical trials.
• The system improved drug availability and reduced stock-outs, supporting continuous site enrollment.