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

Abstract

INTRODUCTION\nEfficient management of study drug inventory shipments is critical to keep research sites enrolling into multisite clinical treatment trials. A standard manual drug-management process used by the Tuberculosis Trials Consortium (TBTC), did not accommodate import permit approval timelines, shipment transit-times and time-zone differences. We compared a new web-based solution with the manual process, during an international 34-site clinical trial conducted by the TBTC and the AIDS Clinical Trials Group (ACTG); TBTC Study 31/ACTG A5349.\n\n\nMATERIAL AND METHODS\nWe developed and implemented a technological solution by integrating logistical and regulatory requirements for drug importation with statistical simulations that estimated stock-out times in an online Drug Management Module (DMM). We measured the average shipment-related drug stock-outs and time to drug availability, to assess the efficiency of the DMM compared to the manual approach.\n\n\nRESULTS\nAn Interrupted Time-Series (ITS) analysis showed a 15% [p-value\u202f=\u202f0.03; 95% C.I. (-28.8%, -2.0%)] reduction in average shipment-related study drug stock-out after DMM implementation. The DMM streamlined the restocking process at study sites, reducing median transit-time for sites associated with a depot by 2\u202fdays [95% C.I. (-3.0, -1.0)]. Under the DMM, study drugs were available for treatment assignment on the day received, compared to one day after receipt under the manual process.\n\n\nDISCUSSION\nThe DMM provided TBTC s Data and Coordinating Center and site staff with more efficient procedures to manage and consistently maintain study drug inventory at enrolling sites. This DMM framework can improve efficiency in future multicenter clinical trials.\n\n\nTRIAL REGISTRATION\nThis trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015.